Pharmaceutical compositions of FCRN antibodies

Abstract

Pharmaceutical compositions of anti-FcRn antibodies and uses thereof are provided herein.

Description

[0001] PHARMACEUTICAL COMPOSITIONS OF FCRN ANTIBODIES

[0002] CROSS REFERNENCE TO RELATED APPLICATIONS

[0003] The present application claims priority to and the benefit of United States patent application no. 63 / 581,914, “PHARMACEUTICAL COMPOSITIONS OF FCRN ANTIBODIES,” which was filed on September 11, 2023, the disclosure of which is hereby incorporated by reference in its entirety.

[0004] SEQUENCE LISITNG

[0005] The instant application contains a Sequence Listing which is being submitted herewith electronically in XML format and is hereby incorporated by reference in its entirety. Said XML copy, created on September 3, 2024, is named 103693_006057_Sequencelisting.xml and is 23 kilobytes in size.

[0006] BACKGROUND

[0007] Anti-FcRn molecules have been tested in various clinical trials. While anti-FcRn antibodies, including nipocalimab, have shown promising results, there remains a need in the art for stable high concentration, low viscosity pharmaceutical compositions comprising anti-FcRn antibodies, suitable for intravenous and / or subcutaneous administration.

[0008] SUMMARY

[0009] Disclosed herein are stable high concentration, low viscosity aqueous pharmaceutical compositions comprising specific formulations of an anti-FcRn antibody. A pharmaceutical composition is provided herein, the pharmaceutical composition comprising: (i) an anti-FcRn antibody, or antigen-binding fragment thereof, at an amount of about 50 mg / mL to about 500 mg / mL; (ii) a buffer at an amount of about 1 mM to about 50 mM; (iii) polyol at an amount of about 1% to about 20% (w / v); (iv) an antioxidant, at an amount of about 0.1 mg / mL to about 10 mg / mL; (v) a viscosity-lowering agent at an amount of about 1 mM to about 500 mM; and (vi) a surfactant at an amount of about 0.001% to about 1% (w / v), wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

[0010] In some embodiments, the anti-FcRn antibody, or antibody fragment thereof, comprises: a) (i) a light chain variable region comprising a light chain complementary determining region (CDR) 1 (CDR1) comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 7; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; b) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 11; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 12; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; c) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 12; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; d) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 17; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; or e) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 18; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 7; and a heavy chain CDR3 sequence comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing.

[0011] In some embodiments, the anti-FcRn antibody comprises a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1. In some embodiments, the anti-FcRn antibody comprises a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16. In some embodiments, the anti-FcRn antibody comprises: a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16.

[0012] In some embodiments, the anti-FcRn antibody comprises: a) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2; b) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 13; c) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 14; d) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 15; or e) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 16.

[0013] In some embodiments, anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1. In some embodiments, the anti-FcRn antibody comprises a heavy chain comprising a sequence of SEQ ID NO: 2, 13, 14, 15, or 16. In some embodiments, the anti-FcRn antibody comprises: a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence of SEQ ID NO: 2, 13, 14, 15, or 16.

[0014] In some embodiments, the anti-FcRn antibody comprises: a) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2; b) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 13; c) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 14; d) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 15; or e) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 16. In some embodiments, the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, the anti-FcRn antibody is nipocalimab.

[0015] In some embodiments, the anti-FcRn antibody (e.g. nipocalimab) comprises: a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 19.

[0016] In some embodiments, the anti-FcRn antibody, or antigen-binding fragment thereof, is present in the pharmaceutical composition at an amount of about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL. In some embodiments, the anti-FcRn antibody, or antigenbinding fragment thereof, is present in the pharmaceutical composition at an amount of about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about mg / mL, about 220 mg / mL, about 225 mg / mL, about 230 mg / mL, about 235 mg / mL, about 240 mg / mL, about 245 mg / mL, or about 250 mg / mL. In some embodiments, the anti-FcRn antibody, or antigenbinding fragment thereof, is present in the pharmaceutical composition at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL. In some embodiments, the anti-FcRn antibody, or antigen-binding fragment thereof, is present in the pharmaceutical composition at an amount of about 230 mg / mL.

[0017] In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 25 mM to about 450 mM, about 50 mM to about 400 mM, about 75 mM to about 350 mM, about 80 mM to about 300 mM, about 90 mM to about 250 mM, or about 100 mM to about 200 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 50 mM, about 60 mM, about 70 mM, about 80 mM, about 90 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of 65 mM, 121 mM, or 150 mM. In some embodiments, the viscosity-lowering agent is selected from the group consisting of arginine, lysine, proline, leucine, methionine, glutamic acid, sodium chloride, mixtures thereof, and pharmaceutically acceptable salts thereof. In some embodiments, the viscosity-lowering agent is arginine, or a pharmaceutically acceptable salt thereof. In some embodiments, the viscosity-lowering agent is arginine hydrochloride. In some embodiments, the viscosity-lowering agent is arginine glutamate.

[0018] In some embodiments, the buffer is a histidine buffer or a phosphate buffer. In some embodiments, the buffer is a histidine buffer. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 1 to about 50 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 11 mM, about 12 mM, about 13 mM, about 14 mM, about 15 mM, about 16 mM, about 17 mM, about 18 mM, about 19 mM, or about 20 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of 10 mM.

[0019] In some embodiments, the polyol is present in the pharmaceutical composition at an amount of about 1% to about 15%, about 2% to about 10%, about 3% to about 10%, about 3% to about 9%, or about 3% to about 8% (w / v). In some embodiments, the polyol is present in the pharmaceutical composition at an amount of about 1%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about

[0020] 4.7%, about 4.8%, about 4.9%, about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about

[0021] 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about

[0022] 6.3%, about 6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about

[0023] 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about

[0024] 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v). In some embodiments, the polyol is present in the pharmaceutical composition at an amount of about 3.5%, about 6.4%, or about 8%. In some embodiments, the polyol is a monosaccharide or a disaccharide. In some embodiments, the monosaccharide is sorbitol. In some embodiments, the disaccharide is sucrose or trehalose. In some embodiments, the polyol is sucrose.

[0025] In some embodiments, the antioxidant is methionine or L-methionine. In some embodiments, the antioxidant is methionine. In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0. 1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0. 1 mg / mL to about 5 mg / mL, about 0. 1 mg / mL to about 4 mg / mL, about 0.1 mg / mL to about 3 mg / mL, about 0.1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL. In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 0.1 mg / mL, about 0.2 mg / mL, about 0.3 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.7 mg / mL, about 0.8 mg / mL, about 0.9 mg / mL, about Img / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.5 mg / mL, about 1.6 mg / mL, about 1.7 mg / mL, about 1.8 mg / mL, about 1.9 mg / mL, or about 2 mg / mL. In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 1 mg / mL.

[0026] In some embodiments, the surfactant is a polysorbate, or a poloxamer. In some embodiments, the polysorbate is polysorbate 80 (PS 80) or polysorbate 20 (PS20). In some embodiments, the polysorbate is PS80. In some embodiments, the PS80 is present in the pharmaceutical composition at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v). In some embodiments, the PS80 is present in the pharmaceutical composition at an amount of about 0.005%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% (w / v). In some embodiments, the PS80 is present at an amount of about 0.06%.

[0027] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0028] In some embodiments, the pH of the pharmaceutical composition is between about 5.5 to 6.5, or about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6, about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5. In some embodiments, the pH of the pharmaceutical composition is about 6.

[0029] In some embodiments, the anti-FcRn antibody, or antigen-binding fragment thereof, is present in the pharmaceutical composition at an amount of about 230 mg / mL. In some embodiments, the arginine HC1 is present in the pharmaceutical composition at an amount of about 150 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 10 mM. In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 8% (w / v). In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 1 mg / mL. In some embodiments, the polysorbate is polysorbate 80 (PS80) is present in the pharmaceutical composition at an amount of about 0.06%. In some embodiments, the pH of the pharmaceutical composition is about 6. In some embodiments, the anti-FcRn antibody, or antigen-binding fragment thereof, is present in the pharmaceutical composition at an amount of about 100 mg / mL. In some embodiments, the arginine HC1 is present in the pharmaceutical composition at an amount of about 65 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 10 mM. In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 3.5% (w / v). In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 1 mg / mL. In some embodiments, the polysorbate is polysorbate 80 (PS80) is present in the pharmaceutical composition at an amount of about 0.06%. In some embodiments, the pH of the pharmaceutical composition is about 6.

[0030] In some embodiments, the anti-FcRn antibody, or antigen-binding fragment thereof, is present in the pharmaceutical composition at an amount of about 185 mg / mL. In some embodiments, the arginine HC1 is present in the pharmaceutical composition at an amount of about 121 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 10 mM. In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 6.4% (w / v). In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 1 mg / mL. In some embodiments, the polysorbate is polysorbate 80 (PS80) is present in the pharmaceutical composition at an amount of about 0.06%. In some embodiments, the pH of the pharmaceutical composition is about 6.

[0031] A pharmaceutical composition is provided, comprising (i) an anti-FcRn antibody, or antigen-binding fragment thereof, at an amount of about 50 mg / mL to about 500 mg / mL; (ii) a histidine buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and (vi) a polysorbate at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

[0032] In some embodiments, the anti-FcRn antibody, or antibody fragment thereof, comprises: (i) a light chain variable region comprising a light chain complementary determining region (CDR) 1 (CDR1) comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 7; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing.

[0033] In some embodiments, the anti-FcRn antibody comprises a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1. In some embodiments, the anti-FcRn antibody comprises a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2. In some embodiments, the anti-FcRn antibody comprises: a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2. In some embodiments, the anti-FcRn antibody comprises: a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, the anti-FcRn antibody is nipocalimab.

[0034] In some embodiments, the anti-FcRn antibody, or antigen-binding fragment thereof, is present in the pharmaceutical composition at an amount of about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL. In some embodiments, the anti-FcRn antibody, or antigenbinding fragment thereof, is present in the pharmaceutical composition at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

[0035] In some embodiments, the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 50 mM, about 60 mM, about 70 mM, about 80 mM, about 90 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM. In some embodiments, the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM. In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable salt of arginine, such as arginine hydrochloride.

[0036] In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 1 mM to about 40 mM, about 1 mM to about 30 mM, or about 1 mM to about 20 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 11 mM, about 12 mM, about 13 mM, about 14 mM, about 15 mM, about 16 mM, about 17 mM, about 18 mM, about 19 mM, or about 20 mM. In some embodiments, the histidine buffer is present at an amount of about 10 mM.

[0037] In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 1% to about 15%, about 2% to about 10%, about 3% to about 10%, about 3% to about 9%, or about 3% to about 8% (w / v). In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 1%, about 1.1%, about 1.2%, about 1.3%, about

[0038] 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about 6.3%, about 6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v). In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 3.5%, about 6.4%, or about 8%.

[0039] In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 0.1 mg / mL to about 9 mg / mL, about 0. 1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0. 1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0. 1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL. In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 0. 1 mg / mL, about 0.2 mg / mL, about 0.3 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.7 mg / mL, about 0.8 mg / mL, about 0.9 mg / mL, about 1 mg / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.5 mg / mL, about 1.6 mg / mL, about 1.7 mg / mL, about 1.8 mg / mL, about 1.9 mg / mL, or about 2 mg / mL. In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 1 mg / mL.

[0040] In some embodiments, the polysorbate is polysorbate 80 (PS80), or polysorbate 20 (PS20). In some embodiments, the polysorbate is PS80. In some embodiments, the PS80 is present in the pharmaceutical composition at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v). In some embodiments, the PS80 is present in the pharmaceutical composition at an amount of about 0.005%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% (w / v). In some embodiments, the PS80 is present at an amount of about 0.06%.

[0041] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0042] In some embodiments, the pH of the pharmaceutical composition is between about 5.5 to 6.5, or about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6, about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5. In some embodiments, the pH of the pharmaceutical composition is about 6.

[0043] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 50 mg / mL to about 500 mg / mL; (ii) a histidine buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) methionine at an amount of about 0.1 mg / mL to about 10 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and (vi) a polysorbate 80 (PS80) at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical compositions is about 5.5 to about 6.5; wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

[0044] In some embodiments, the anti-FcRn antibody is present in the pharmaceutical composition at an amount of about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL. In some embodiments, the anti-FcRn antibody is present in the pharmaceutical composition at an amount of about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about mg / mL, about 220 mg / mL, about 225 mg / mL, about 230 mg / mL, about 235 mg / mL, about 240 mg / mL, about 245 mg / mL, or about 250 mg / mL. In some embodiments, the anti-FcRn antibody is present in the pharmaceutical composition at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

[0045] In some embodiments, the arginine, or pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 25 mM to about 450 mM, about 50 mM to about 400 mM, about 75 mM to about 350 mM, about 80 mM to about 300 mM, about 90 mM to about 250 mM, or about 100 mM to about 200 mM. In some embodiments, the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 50 mM, about 60 mM, about 70 mM, about 80 mM, about 90 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM. In some embodiments, the arginine, or the pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM. In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable salt of arginine, such as arginine hydrochloride.

[0046] In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 1 mM to about 40 mM, about 1 mM to about 30 mM, or about 1 mM to about 20 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 11 mM, about 12 mM, about 13 mM, about 14 mM, about 15 mM, about 16 mM, about 17 mM, about 18 mM, about 19 mM, or about 20 mM. In some embodiments, the histidine buffer is present in the pharmaceutical composition at an amount of about 10 mM.

[0047] In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 1% to about 15%, about 2% to about 10%, about 3% to about 10%, about 3% to about 9%, or about 3% to about 8% (w / v). In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 1%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about 6.3%, about 6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v). In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 3.5%, about 6.4%, or about 8%.

[0048] In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 0.1 mg / mL to about 9 mg / mL, about 0. 1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0. 1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0. 1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL. In some embodiments, in the methionine is present in the pharmaceutical composition at an amount of about 0.1 mg / mL, about 0.2 mg / mL, about 0.3 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.7 mg / mL, about 0.8 mg / mL, about 0.9 mg / mL, about 1 mg / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.5 mg / mL, about 1.6 mg / mL, about 1.7 mg / mL, about 1.8 mg / mL, about 1.9 mg / mL, or about 2 mg / mL. In some embodiments, the methionine is present in the pharmaceutical composition at an amount of about 1 mg / mL.

[0049] In some embodiments, the PS 80 is present in the pharmaceutical composition at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v). In some embodiments, the PS80 is present in the pharmaceutical composition at an amount of about 0.005%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% (w / v). In some embodiments, the PS80 is present at an amount of about 0.06%.

[0050] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0051] In some embodiments, the pH of the pharmaceutical composition is between about 5.5 to about 6.5, or about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6, about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5. In some embodiments, the pH of the pharmaceutical composition is about 6.

[0052] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 100 mg / mL to about 250 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 3% to about 8% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 50 mM to about 200 mM; (vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

[0053] In some embodiments, the anti-FcRn antibody is present in the pharmaceutical composition at an amount of about 100 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about mg / mL, about 220 mg / mL, about 225 mg / mL, or about 230 mg / mL. In some embodiments, the anti-FcRn antibody is present in the pharmaceutical composition at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

[0054] In some embodiments, the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM. In some embodiments, the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM. In some embodiments, the pharmaceutically acceptable salt of arginine is arginine hydrochloride.

[0055] In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about 6.3%, about 6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v). In some embodiments, the sucrose is present in the pharmaceutical composition at an amount of about 3.5%, about 6.4%, or about 8%.

[0056] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0057] In some embodiments, in any pharmaceutical composition herein, some or all of the amount of a heavy chain of the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody, the heavy chain of the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, in about 1-2% of the amount of anti-FcRn antibody, a heavy chain of the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibodies in the composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies in the composition further comprise an additional lysine residue at the C- terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21).

[0058] In some embodiments, in any pharmaceutical composition herein, some or all of the amount of a heavy chain of the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, in about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the amount of anti-FcRn antibody, a heavy chain of the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of a heavy chain of the anti-FcRn antibody in the composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.5- 1.0% of the heavy chains of the anti-FcRn antibodies in the composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0059] In some embodiments, in any pharmaceutical composition herein, about 1-2% of the heavy chains of the anti-FcRn antibodies in the composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21) and about 0.5- 1.0% of the heavy chains of the anti-FcRn antibodies in the composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline of said heavy chain may be amidated.

[0060] In some embodiments, in any pharmaceutical composition herein, some or all of the amount of a heavy chain of the anti-FcRn antibody lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, in about 0. 1-1%, or about 0.2- 1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the amount of anti-FcRn antibody, a heavy chain of the anti-FcRn antibody lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3- 1.0%, or about 0.5-1.0% of a heavy chain of the anti-FcRn antibody in the composition lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 0.5-1.0% of the heavy chains of the anti-FcRn antibodies in the composition lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19).

[0061] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 185 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 6.4% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 121 mM; (vi) a polysorbate 80 (PS 80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti- FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

[0062] In some embodiments, some or all of the anti-FcRn antibody present in the pharmaceutical composition further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, in about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21).

[0063] In some embodiments, some or all of the anti-FcRn antibody present in the pharmaceutical composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, in about 0.1-1%, or about 0.2- 1.0%, or about 0.3- 1.0%, or about 0.5-1.0% of the anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.5- 1.0% of the heavy chains of the anti- FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0064] In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21) and about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline of said heavy chain may be amidated.

[0065] In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19).

[0066] In some embodiments, the pharmaceutical composition is administered intravenously, is for intravenous administration, or is for use by intravenous administration.

[0067] In some embodiments, the pharmaceutical composition is used in, or the pharmaceutical composition is suitable or intended for use in, the treatment of hemolytic disease of fetus and newborn (HDFN), fetal neonatal alloimmune thrombocytopenia (FNAIT), congenital heart block (CHB), warm autoimmune hemolytic anemia (wAIHA), bullous pemphigoid (BP), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and / or idiopathic inflammatory myopathies (IIM).

[0068] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 185 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 6.4% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 121 mM; (vi) a polysorbate 80 (PS 80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti- FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 19.

[0069] In some embodiments, the pharmaceutical composition is administered intravenously, is for intravenous administration, or is for use by intravenous administration.

[0070] In some embodiments, the pharmaceutical composition is used in, or the pharmaceutical composition is suitable or intended for use in, the treatment of hemolytic disease of fetus and newborn (HDFN), fetal neonatal alloimmune thrombocytopenia (FNAIT), congenital heart block (CHB), warm autoimmune hemolytic anemia (wAIHA), bullous pemphigoid (BP), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and / or idiopathic inflammatory myopathies (IIM).

[0071] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 100 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 3.5% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 65 mM; (vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

[0072] In some embodiments, some or all of the anti-FcRn antibody present in the pharmaceutical composition further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, in about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21).

[0073] In some embodiments, some or all of the anti-FcRn antibody present in the pharmaceutical composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, in about 0.1-1%, or about 0.2- 1.0%, or about 0.3- 1.0%, or about 0.5-1.0% of the anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.5- 1.0% of the heavy chains of the anti- FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0074] In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21) and about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline of said heavy chain may be amidated.

[0075] In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19).

[0076] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0077] In some embodiments, the pharmaceutical composition is administered subcutaneously, is for subcutaneous administration, or is for use by subcutaneous administration. In some embodiments, the pharmaceutical composition is administered via an on-body delivery system (OBDS), is for administration via an on-body delivery system (OBDS), or is for use by administration via an on-body delivery system (OBDS).

[0078] In some embodiments, the pharmaceutical composition is used in, or the pharmaceutical composition is suitable or intended for use in, the treatment of warm autoimmune hemolytic anemia (wAIHA), bullous pemphigoid (BP), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), or idiopathic inflammatory myopathies (IIM).

[0079] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 100 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 3.5% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 65 mM; (vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 19.

[0080] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0081] In some embodiments, the pharmaceutical composition is administered subcutaneously, is for subcutaneous administration, or is for use by subcutaneous administration. In some embodiments, the pharmaceutical composition is administered via an on-body delivery system (OBDS), is for administration via an on-body delivery system (OBDS), or is for use by administration via an on-body delivery system (OBDS).

[0082] In some embodiments, the pharmaceutical composition is used in, or the pharmaceutical composition is suitable or intended for use in, the treatment of warm autoimmune hemolytic anemia (wAIHA), bullous pemphigoid (BP), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), or idiopathic inflammatory myopathies (IIM).

[0083] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 230 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 8% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 150 mM; (vi) a polysorbate 80 (PS 80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti- FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

[0084] In some embodiments, some or all of the anti-FcRn antibody present in the pharmaceutical composition further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, in about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21).

[0085] In some embodiments, some or all of the anti-FcRn antibody present in the pharmaceutical composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, in about 0.1-1%, or about 0.2- 1.0%, or about 0.3- 1.0%, or about 0.5-1.0% of the anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.5- 1.0% of the heavy chains of the anti- FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0086] In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21) and about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline of said heavy chain may be amidated.

[0087] In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19).

[0088] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0089] In some embodiments, the pharmaceutical composition is administered subcutaneously, is for subcutaneous administration, or us for use by subcutaneous administration. In some embodiments, the pharmaceutical composition is formulated for administration via a pre-filled syringe (PFS).

[0090] In some embodiments, the pharmaceutical composition is used in the treatment of rheumatoid arthritis, Sjogren’s disease, systemic lupus erythematosus, and lupus nephritis.

[0091] A pharmaceutical composition is provided, comprising: (i) an anti-FcRn antibody at an amount of about 230 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 8% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 150 mM; (vi) a polysorbate 80 (PS 80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti- FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 19.

[0092] In some embodiments, the pharmaceutical composition further comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0093] In some embodiments, the pharmaceutical composition is administered subcutaneously, is for subcutaneous administration, or us for use by subcutaneous administration. In some embodiments, the pharmaceutical composition is formulated for administration via a pre-filled syringe (PFS).

[0094] In some embodiments, the pharmaceutical composition is used in the treatment of rheumatoid arthritis, Sjogren’s disease, systemic lupus erythematosus, and lupus nephritis.

[0095] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 19.

[0096] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein, in about 0. 1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, in about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2.

[0097] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibodies comprise a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein about 0.1-10%, or about 0.5- 8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21).

[0098] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein, in about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, in about 0.5- 1.0% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0099] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibodies comprise a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein about 0.1-1%, or about 0.2- 1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 0.5-1.0% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0100] In some embodiments, about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lacks the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 0.5-1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19).

[0101] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein a) in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21); and b) in about 0.1-1%, or about 0.2-1.0%, or about 0.3- 1.0%, or about 0.5-1.0% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein in about 1-2% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21); and in about 0.5-1.0% of the amount of anti-FcRn antibody present in the pharmaceutical composition, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0102] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein a) about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21); and b) about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0103] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein about 1-2% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21); and about 0.5- 1.0% of the heavy chains of the anti-FcRn antibody present in the pharmaceutical composition lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C- terminal proline may be amidated.

[0104] A pharmaceutical composition is provided, comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein about 0.1-1%, or about 0.2- 1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains of the anti-FcRn antibodies present in the pharmaceutical composition lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, the pharmaceutical composition comprises a viscosity at 25°C of less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP. In some embodiments, the pharmaceutical composition comprises a viscosity at 25°C of less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP, after storage for about 24 months or more and at a temperature of about 5°C. In some embodiments, the formulation has a viscosity at 25°C of less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP, after storage for about 12 months or more and at a temperature of about 25°C.

[0105] In some embodiments, any of the pharmaceutical compositions disclosed herein are suitable for intravenous or subcutaneous administration, or is for use by intravenous or subcutaneous administration.

[0106] In some embodiments, any of the pharmaceutical compositions disclosed herein are administered, or is for administration, or is for use by administration, using an infusion pump, a patch pump, an autoinjector, a wearable injector, or an on-body delivery system (OBDS).

[0107] In some embodiments, any of the pharmaceutical compositions disclosed herein are a liquid pharmaceutical composition.

[0108] In some embodiments, any of the pharmaceutical compositions disclosed herein are stable at a temperature of about 2-8°C for after at least six months, after at least one year, or after at least two years. In some embodiments, stability is defined based on color of solution, pH, turbidity, percentage of main component (MC), percentage of high molecular weight species (HMWS), percentage of low molecular weight species (LMWS), percentage of sum of acidic peaks, percentage of sum of basic peaks, protein concentration, or any combination thereof. In some embodiments, stability is defined as having a pH range of 5.5 to about 6.5 after storage for about 24 months or more and at a temperature of about 5°C. In some embodiments, stability is defined as having a pH range of 5.5 to about 6.5 after storage for about 12 months or more and at a temperature of about 25 °C. In some embodiments, stability is defined as having a HMWS of about 5.0% or less after storage for about 24 months or more and at a temperature of about 5 °C. In some embodiments, stability is defined as having a HMWS of about 5.0% or less after storage for about 12 months or more and at a temperature of about 25°C.

[0109] A pharmaceutical product is provided herein, comprising any of the pharmaceutical compositions disclosed herein in a container. In some embodiments, the container is a plastic vial, glass vial, or cartridge. In some embodiments, the container is a pre-filled syringe. In some embodiments, the container is an autoinjector.

[0110] A kit is provided herein, comprising any of the pharmaceutical compositions disclosed herein, or any pharmaceutical product disclosed herein, and instructions for use. A method of treating a disease is provided, the method comprising administering to a subject any pharmaceutical composition disclosed herein.

[0111] A use in treating a disease is provided, the use comprising administering to a subject any pharmaceutical composition disclosed herein.

[0112] In some embodiments, in any method of treating a disease or use in treating a disease provided herein, the disease is an immune disease selected from the group consisting of lupus nephritis, myasthenia gravis, autoimmune hemolytic anemia (AIHA), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjogren’s disease, systemic lupus erythematosus, bullous pemphigoid, idiopathic inflammatory myopathies, and rheumatoid arthritis. In some embodiments, the disease is a maternal fetal indication selected from the group consisting of hemolytic disease of the fetus and newborn (HDFN), congenital heart block (CHB), and fetal and neonatal alloimmune thrombocytopenia (FNAIT).

[0113] Also provided herein are methods for preparing a formulation, the method comprising the steps of: a) providing an input solution comprising one or more proteins; b) subjecting the input solution to diafdtration, using a diafdtration solution, until at least an 8-fold to 12-fold volume exchange with the diafdtration solution has been achieved, thereby forming an output solution; and c) concentrating said one or more proteins in the output solution within a range of about 150 to about 250 mg / mL. In some embodiments, the diafdtration solution comprises: (i) a histidine buffer at an amount of about 15.2 mM; (ii) sucrose at an amount of about 10.7% (w / v); (iii) methionine at an amount of about 1.45 mg / mL; (iv) arginine hydrochloride at an amount of about 195 mM; wherein the pH of the diafdtration solution is about 6. In some embodiments, the input solution further comprises: (i) acetate at 100 mM; (ii) NaCl at 75 mM; wherein the pH of the input solution is about 5.5. In some embodiments, the one or more proteins is an antibody, or antigen binding fragment thereof. In some embodiments, the antibody, or antigen-binding fragment thereof, is an anti-FcRn antibody. Also provided herein is a formulation prepared according to any method disclosed herein. Also provided herein is a diafdtration solution comprising: (i) a histidine buffer at an amount of about 15.2 mM; (ii) sucrose at an amount of about 10.7% (w / v); (iii) methionine at an amount of about 1.45 mg / mL; and (iv) arginine hydrochloride at an amount of about 195 mM; wherein the pH of the diafdtration solution is about 6. BRIEF DESCRIPTION OF DRAWINGS

[0114] FIG. 1 provides tabular data illustrating compositions of experimental pharmaceutical compositions.

[0115] FIG. 2 provides tabular data illustrating the percent of high molecular weight species (HMWS) after storage for three weeks at 40°C.

[0116] FIG. 3 provides a flow chart illustrating an overview of an ultrafiltration / diafiltration (UF / DF) process, along with single-pass tangential flow filtration (TFF) and final formulation processes.

[0117] DETAILED DESCRIPTION

[0118] The present disclosure provides for pharmaceutical compositions of antibodies against human neonatal Fc receptor (FcRn). Anti-FcRn antibodies are useful, e.g., to promote clearance of autoantibodies in a subject, to suppress antigen presentation in a subject, to block an immune response, e.g., block an immune complex-based activation of the immune response in a subject, or to treat immunological diseases (e.g., autoimmune diseases) in a subject.

[0119] In some embodiments, the anti-FcRn antibody is nipocalimab, which can also be referred to as M281. Nipocalimab is an antibody that binds to human neonatal Fc receptor (FcRn). Nipocalimab is described in US Patent No. 10,676,526, PCT Publication No. W02020 / 023310, PCT Publication No. W02020 / 018910, each of which are hereby incorporated by reference in their entirety. As used herein, "nipocalimab" is the International Nonproprietary Name (INN) of an antibody that may comprise a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence selected from the group consisting of SEQ ID NOs: 2, 19, 20 and 21. In some embodiments, nipocalimab comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some or all of the heavy chain of nipocalimab may comprise an additional lysine residue at the C- terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 21). In some embodiments, some or all of the heavy chains of nipocalimab may be missing the glycine residue at the C-terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 20). In some embodiments, some or all of the heavy chains of nipocalimab may be missing the glycine residue at the C-terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 20) and, additionally, the C-terminal proline may be amidated.

[0120] As used herein, the terms "a" or "an" means that "at least one" or "one or more" unless the context clearly indicates otherwise.

[0121] As used herein, the term "about" means that the numerical value is approximate and small variations would not significantly affect the practice of the disclosed embodiments. Where a numerical limitation is used, unless indicated otherwise by the context, "about" means the numerical value can vary by + / -10% and remain within the scope of the disclosed embodiments. Additionally, although a value may be preceded by the term “about” the exact value is also provided for herein, i.e., without the term “about.”

[0122] The term “antibody”, as used herein, is used in the broadest sense and encompasses various antibody structures, including but not limited to monoclonal antibodies, polyclonal antibodies, multispecific antibodies (e.g., bispecific antibodies), scFvs, nanobodies, VHH, and antibody fragments so long as they exhibit FcRn antigen-binding activity.

[0123] “Antibody fragments” comprise a portion of an intact antibody, including the antigen binding or variable region of the intact antibody. Examples of antibody fragments include Fab, Fab’, F(ab’)2, and Fv fragments, diabodies, linear antibodies, single-chain antibody molecules, and multispecific antibodies.

[0124] Additionally, antibody or antibody molecule, as that term is used herein, refers to a polypeptide, e.g., an immunoglobulin chain or fragment thereof, comprising at least one functional immunoglobulin variable domain sequence. An antibody molecule encompasses antibodies (e.g., full-length antibodies) and antibody fragments. In some embodiments, an antibody molecule comprises an antigen binding or functional fragment of a full-length antibody, or a full-length immunoglobulin chain. For example, a full-length antibody is an immunoglobulin (Ig) molecule (e.g., an IgG antibody) that is naturally occurring or formed by normal immunoglobulin gene fragment recombinatorial processes). In embodiments, an antibody molecule refers to an immunologically active, antigen-binding portion of an immunoglobulin molecule, such as an antibody fragment. An antibody fragment, e.g., functional fragment, comprises a portion of an antibody, e.g., Fab, Fab', F(ab')2, F(ab)2, variable fragment (Fv), domain antibody (dAb), or single chain variable fragment (scFv). A functional antibody fragment binds to the same antigen as that recognized by the intact (e.g., full-length) antibody. The terms “antibody fragment” or “functional fragment” also include isolated fragments consisting of the variable regions, such as the “Fv” fragments consisting of the variable regions of the heavy and light chains or recombinant single chain polypeptide molecules in which light and heavy variable regions are connected by a peptide linker (“scFv proteins”). In some embodiments, an antibody fragment does not include portions of antibodies without antigen binding activity, such as Fc fragments or single amino acid residues. Exemplary antibody molecules include full length antibodies and antibody fragments, e.g., dAb (domain antibody), single chain, Fab, Fab’, and F(ab’)2 fragments, and single chain variable fragments (scFvs). As used herein, the term “isolated antibody” refers to an antibody which has been separated and / or recovered from a component of its manufacturing host cell environment. Contaminant components of its manufacturing host cell environment are materials which would interfere with research, diagnostic, or therapeutic uses of the antibody. Contaminant components may include enzymes, hormones, and other proteinaceous or nonproteinaceous solutes. In some embodiments, an antibody is purified (1) to greater than 95% by weight of antibody as determined by, for example, the Lowry method, and in some embodiments, to greater than 99% by weight; (2) to a degree sufficient to obtain at least 15 residues of N-terminal or internal amino acid sequence by use of, for example, a spinning cup sequenator, or (3) to homogeneity by SDS-PAGE under reducing or nonreducing conditions using, for example, Coomassie blue or silver stain. An isolated antibody includes the antibody in situ within recombinant cells. Ordinarily, however, an isolated antibody will be prepared by at least one purification step. A pharmaceutical preparation of an isolated antibody typically has less than 250 ppm (e.g., less than 200ppm, 150ppm. 100 ppm) of host cell proteins (HCP) as determined by an ELISA based HCP assay performed as recommended by an FDA “Guidance for Industry” document.

[0125] As used herein, the term “baseline” in reference to amount, concentration or level of a molecule refers to the amount, concentration, or level of the molecule prior to the administration of a therapeutic (e.g., antibody) provided for herein.

[0126] As used herein, the terms "comprising" (and any form of comprising, such as "comprise", "comprises", and "comprised"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include"), or "containing" (and any form of containing, such as "contains" and "contain"), are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. Any step or composition that uses the transitional phrase of "comprise" or "comprising" can also be said to describe the same with the transitional phases of "consisting of," "consists," “consisting essentially of,” or “consists essentially of.”

[0127] Immunoglobulin chains exhibit the same general structure of relatively conserved framework regions (FR) joined by three hypervariable regions, also called complementarity determining regions or CDRs. The CDRs from the two chains of each pair are aligned by the framework regions, enabling binding to a specific epitope. From N-terminus to C-terminus, both light and heavy chains comprise the domains FR1, CDR1, FR2, CDR2, FR3, CDR3 and FR4. The assignment of amino acids to each domain is in accordance with the definitions of Kabat Sequences of Proteins of Immunological Interest (National Institutes of Health, Bethesda, Md. (1987 and 1991)), or Chothia & Lesk J. Mol. Biol. 196:901-917 (1987); Chothia et al. Nature 342:878-883 (1989), each of which is hereby incorporated by reference in its entirety. In some embodiments, the antibodies provided herein comprise the same FRs and different CDRs. In some embodiments, the antibodies provided herein comprise the same CDRs and different FRs. In some embodiments, mutations in the FR are in the heavy chain. In some embodiments, mutations in the FR are in the FR1 of the heavy chain. In some embodiments, mutations in the FR are in the FR2 of the heavy chain. In some embodiments, mutations in the FR are in the FR3 of the heavy chain. In some embodiments, mutations in the FR are in the FR4 of the heavy chain. In some embodiments, mutations in the FR are in the light chain. In some embodiments, mutations in the FR are in the FR1 of the light chain. In some embodiments, mutations in the FR are in the FR2 of the light chain. In some embodiments, mutations in the FR are in the FR3 of the light chain. In some embodiments, mutations in the FR are in the FR4 of the light chain. In some embodiments, mutations in the FR are in the heavy and light chains. In some embodiments, mutations in the FR are in any one or more of the FRs of the heavy and light chains.

[0128] The term “antibody molecule” also encompasses whole or fragments of antigen binding domain, or single domain antibodies, which can also be referred to as “sdAb” or “VHH.” Domain antibodies comprise either VH or VL that can act as stand-alone, antibody fragments. Additionally, domain antibodies include heavy-chain-only antibodies (HCAbs). Domain antibodies also include a CH2 domain of an IgG as the base scaffold into which CDR loops are grafted. It can also be generally defined as a polypeptide or protein comprising an amino acid sequence that is comprised of four framework regions interrupted by three complementarity determining regions. This is represented as FR1-CDR1-FR2-CDR2-FR3-CDR3-FR4. sdAbs can be produced in camelids such as llamas, but can also be synthetically generated using techniques that are well known in the art. The numbering of the amino acid residues of a sdAb or polypeptide is according to the general numbering for VH domains given by Kabat et al. ("Sequence of proteins of immunological interest," US Public Health Services, NIH Bethesda, MD, Publication No. 91, which is hereby incorporated by reference in its entirety). According to this numbering, FR1 of a sdAb comprises the amino acid residues at positions 1-30, CDR1 of a sdAb comprises the amino acid residues at positions 31-36, FR2 of a sdAb comprises the amino acids at positions 36-49, CDR2 of a sdAb comprises the amino acid residues at positions 50-65, FR3 of a sdAb comprises the amino acid residues at positions 66- 94, CDR3 of a sdAb comprises the amino acid residues at positions 95- 102, and FR4 of a sdAb comprises the amino acid residues at positions 103-113. Domain antibodies are also described in W02004041862 and WO2016065323, each of which is hereby incorporated by reference in its entirety. In some embodiments, as provided for herein, antibody molecules can be monospecific (e.g., monovalent or bivalent), bispecific (e.g., bivalent, trivalent, tetravalent, pentavalent, or hexavalent), trispecific (e.g., trivalent, tetravalent, pentavalent, hexavalent), or with higher orders of specificity (e.g., tetraspecific) and / or higher orders of valency beyond hexavalency. An antibody molecule can comprise a functional fragment of a light chain variable region and a functional fragment of a heavy chain variable region, or heavy and light chains may be fused together into a single polypeptide.

[0129] As used herein, the term “fused” or “linked” when used in reference to a protein having different domains or heterologous sequences means that the protein domains are part of the same peptide chain that are connected to one another with either peptide bonds or other covalent bonding. The domains or section can be linked or fused directly to one another, or another domain or peptide sequence can be between the two domains or sequences and such sequences would still be considered fused or linked to one another. In some embodiments, the various domains or proteins provided for herein are linked or fused directly to one another or a linker sequences, such as a glycine / serine, glycine / alanine linker or other types of peptide linkers generally known to link the two domains together. Two peptide sequences are linked directly if they are directly connected to one another or indirectly if there is a linker or other structure that links the two regions. A linker can be directly linked to two different peptide sequences or domains.

[0130] As used herein, the terms “variable region” and “variable domain” refer to the portions of the light and heavy chains of an antibody that include amino acid sequences of complementary determining regions (CDRs, e g., CDR LI, CDR L2, CDR L3, CDR Hl, CDR H2, and CDR H3) and framework regions (FRs). According to the methods used in this disclosure, the amino acid positions assigned to CDRs and FRs are defined according to Kabat (Sequences of Proteins of Immunological Interest, 5th Ed. Public Health Service, National Institutes of Health, Bethesda, MD. (1991), which is hereby incorporated by reference in its entirety). Using this numbering system, the actual linear amino acid sequence may contain fewer or additional amino acids corresponding to a shortening of, or insertion into, a CDR (defined further herein) or FR (defined further herein) of the variable region. For example, a heavy chain variable region may include a single inserted residue (i.e., residue 52a according to Kabat) after residue 52 of CDR H2 and inserted residues (i.e., residues 82a, 82b, 82c, etc. according to Kabat) after residue 82 of heavy chain FR. The Kabat numbering of residues may be determined for a given antibody by alignment at regions of homology of the sequence of the antibody with a “standard” Kabat numbered sequence.

[0131] As used herein, the terms “complementary determining regions” and “CDRs” refer to the regions of an antibody variable domain or variable region which are hypervariable in sequence and / or form structurally defined loops. A CDR is also known as a hypervariable region. The light chain and heavy chain variable regions each have three CDRs. The light chain variable region contains CDR LI, CDR L2, and CDR L3. The heavy chain variable region contains CDR Hl, CDR H2, and CDR H3. Each CDR may include amino acid residues from a complementarity determining region as defined by Kabat (i.e., about residues 24-34 (CDR LI), 50-56 (CDR L2) and 89-97 (CDR L3) in the light chain variable region and about residues 31-35 (CDR Hl), 50-65 (CDR H2) and 95- 102 (CDR H3) in the heavy chain variable region.

[0132] As used herein, the term “FcRn” refers a neonatal Fc receptor that binds to the Fc region of an IgG antibody, e.g., an IgGl antibody. An exemplary FcRn is human FcRn having UniProt ID No. P55899, which is hereby incorporated by reference in its entirety. Without being bound to any particular theory, human FcRn is believed to be responsible for maintaining the half-life of IgG by binding and trafficking constitutively internalized IgG back to the cell surface for the recycling of IgG.

[0133] In some embodiments, the anti-FcRn antibody comprises a heavy chain or light chain. In some embodiments, the anti-FcRn antibody comprises a heavy chain and a light chain in a scFv format. In some embodiments, the heavy and light chain are linked with a peptide linker, such a glycine / serine or glycine / alanine linker.

[0134] As used herein, the term “percent (%) identity” refers to the percentage of amino acid (or nucleic acid) residues of a candidate sequence, e.g., an anti-FcRn antibody of the disclosure, that are identical to the amino acid (or nucleic acid) residues of a reference sequence, e.g., a wild-type anti- FcRn antibody, after aligning the sequences and introducing gaps, if necessary, to achieve the maximum percent identity (i.e., gaps can be introduced in one or both of the candidate and reference sequences for optimal alignment and non-homologous sequences can be disregarded for comparison purposes). Alignment for purposes of determining percent identity can be achieved in various ways that are within the skill in the art, for instance, using publicly available computer software such as BLAST, ALIGN, or Megalign (DNASTAR) software. Those skilled in the art can determine appropriate parameters for measuring alignment, including any algorithms needed to achieve maximal alignment over the full length of the sequences being compared. In some embodiments, the percent amino acid (or nucleic acid) sequence identity of a given candidate sequence to, with, or against a given reference sequence (which can alternatively be phrased as a given candidate sequence that has or includes a certain percent amino acid (or nucleic acid) sequence identity to, with, or against a given reference sequence) is calculated as follows:

[0135] 100 x (fraction of A / B) where A is the number of amino acid (or nucleic acid) residues scored as identical in the alignment of the candidate sequence and the reference sequence, and where B is the total number of amino acid (or nucleic acid) residues in the reference sequence. In some embodiments where the length of the candidate sequence does not equal to the length of the reference sequence, the percent amino acid (or nucleic acid) sequence identity of the candidate sequence to the reference sequence would not equal to the percent amino acid (or nucleic acid) sequence identity of the reference sequence to the candidate sequence.

[0136] In some embodiments, a reference sequence aligned for comparison with a candidate sequence may show that the candidate sequence exhibits from 50% to 100% identity across the full length of the candidate sequence or a selected portion of contiguous amino acid (or nucleic acid) residues of the candidate sequence. The length of the candidate sequence aligned for comparison purpose is at least 30%, e.g., at least 40%, e.g., at least 50%, 60%, 70%, 80%, 90%, or 100% of the length of the reference sequence. When a position in the candidate sequence is occupied by the same amino acid (or nucleic acid) residue as the corresponding position in the reference sequence, then the molecules are identical at that position. A position may be altered by a substitution, deletion, or insertion. A substitution, deletion, or insertion may comprise a certain number of amino acids, (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or more). When describing a substitution, deletion, or insertion of no more than n amino acids, this is meant that the substitution, deletion, or insertion comprises, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or n amino acids. The number or substitutions, deletions, or insertions can comprise a percent of the total sequence (e.g., 1%, 5%, 10%, 15%, 20%, or more) where the number of substitutions, deletions, or insertions alters 5%, 10%, 15%, 20% or more, of the amino acids in the total sequence.

[0137] As used herein, the term “pathogenic antibody” refers to an antibody that causes one or more immune diseases or disorders in a subject (e.g., a pregnant subject), a fetus in a pregnant subject, and / or a neonate. In some embodiments, pathogenic antibodies are autoantibodies produced in a subject (e.g., a pregnant subject) against one or more of the subject’s own proteins, thus causing autoimmune diseases or disorders in the subject. In some embodiments, pathogenic antibodies in a pregnant subject may transfer through the placenta to the fetus and react against antigens from the fetus (e.g., antigens that the fetus inherited from the fetus’ father), thus causing, e.g., fetal and neonatal alloimmune and / or autoimmune disorders.

[0138] As used herein, the term “antibody-mediated enhancement of viral disease” refers to a viral disease in which antibodies can facilitate viral entry into host cells, thus leading to increased or enhanced infectivity in the cells. In some embodiments, an antibody may bind to a viral surface protein and the antibody / virus complex may bind to an FcRn receptor on a cell surface through interaction between the antibody and the receptor. Subsequently, the antibody / virus complex may be internalized into the cell. As used herein, the term “pharmaceutical composition” refers to a medicinal or pharmaceutical formulation that contains an active ingredient and optionally one or more excipients and diluents to enable the active ingredient suitable for the method of administration. In some embodiments, the pharmaceutical composition of the present disclosure includes pharmaceutically acceptable components that are compatible with the anti-FcRn antibody. The pharmaceutical composition may be in aqueous form for intravenous or subcutaneous administration or in tablet or capsule form for oral administration.

[0139] As used herein, “stable” or “stability” refers to the pharmaceutical composition and the extent to which the bispecific antibody, or antigen binding fragment thereof, retains, within specified limits and throughout its period of storage and use, the same or nearly the same properties and characteristics that is possessed at the time of its manufacture. These antibody (or antigen binding fragment thereof) properties and characteristics can be, for example, activity, aggregation or lack thereof, degradation products or lack thereof, or other relevant measurements. Thus, in some embodiments, any pharmaceutical composition disclosed herein may be stable, or retain stability, for a given period. For example, in some embodiments, the pharmaceutical composition is stable at a temperature of about 2-8°C after at least six months, after at least one year, or after at least two years.

[0140] As used herein, the term “pharmaceutically acceptable carrier” refers to an excipient or diluent in a pharmaceutical composition. The pharmaceutically acceptable carrier must be compatible with the other ingredients of the formulation and not deleterious to the recipient. In the present disclosure, the pharmaceutically acceptable carrier must provide adequate pharmaceutical stability to the Fc construct. The nature of the carrier differs with the mode of administration. For example, for intravenous administration, an aqueous solution carrier is generally used; for oral administration, a solid carrier is generally used.

[0141] As used herein, the term “therapeutically effective amount” refers to an amount, e.g., pharmaceutical dose, effective in inducing a desired biological effect in a subject or patient or in treating a patient having a condition or disorder described herein. It is also to be understood herein that a “therapeutically effective amount” may be interpreted as an amount giving a desired therapeutic effect, either taken in one dose or in any dosage or route, taken alone or in combination with other therapeutic agents.

[0142] As used herein, the term “no more than” refers to an amount that is less than or equal to. This may be an amount in integers. For example, no more than two substitutions can refer to 0, 1, or 2 substitutions. As used herein, the terms “treatment” or “treating” refer to reducing, decreasing, decreasing the risk of, or decreasing the side effects of a particular disease or condition. Reducing, decreasing, decreasing the risk of, or decreasing the side effects of are relative to a subject who did not receive treatment, e.g., a control, a baseline, or a known control level or measurement.

[0143] Described herein is a method for administration of anti-FcRn antibodies, such as preferably nipocalimab. The methods can include the administration of a loading dose followed 1 week, 2 weeks, 3 weeks, or 4 weeks later by the initiation of weekly, biweekly, every 3 weeks, or monthly dosing at a maintenance dose lower than the loading dose (e.g., a dose that is about 75%, about 50%, about 25%, about 20%, about 15%, about 10%, or about 5% of the loading dose. The antibodies can be administered by IV or subcutaneously relatively rapidly, yet safely.

[0144] Anti-FcRn antibodies

[0145] In some embodiments, the anti-FcRn antibody is M281. In some embodiments, the anti- FcRn antibody is nipocalimab. As used herein, “M281” and “nipocalimab” refer to the same antibody and can be used interchangeably. In some embodiments, M281 or nipocalimab comprise a light chain comprising or consisting of the sequence of SEQ ID NO: 1 and a heavy chain comprising or consisting of a sequence selected from the group consisting of SEQ ID NOs: 2, 19, 20 and 21. In some embodiments, M281 or nipocalimab comprise a light chain comprising or consisting of the sequence of SEQ ID NO: 1 and a heavy chain comprising or consisting of the sequence of SEQ ID NO: 2. In some embodiments, some or all of the heavy chains of nipocalimab may comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 21). In some embodiments, some or all of the heavy chains of nipocalimab may be missing the glycine residue at the C-terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 20). In some embodiments, some or all of the heavy chains of nipocalimab may be missing the glycine residue at the C-terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 20) and, additionally, the C-terminal proline may be amidated. In some embodiments, some or all of the heavy chains of nipocalimab may be missing the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (for example, as in SEQ ID NO: 19).

[0146] The term "nipocalimab” as used herein is intended to encompass biosimilar anti-FcRn antibodies that are equivalent to the nipocalimab protein developed and marketed by Johnson and Johnson. For example, a biosimilar of nipocalimab may be acceptable to the European Medicines Agency (EMA) and / or the United States Food and Drug Administration (FDA) when it has essentially the same pharmacological effects as the reference product nipocalimab. For example, a biosimilar of nipocalimab may comprise or consist of the same heavy and light chains sequences as nipocalimab, with the exception that the C-terminal amino acid of the heavy chain may be absent, e.g. compared to SEQ ID NO: 2.

[0147] Nipocalimab may comprise a mixture of different species, wherein the C-terminal end of the heavy chain may differ between different species of nipocalimab. In some embodiments, nipocalimab may comprise a mixture of different heavy chains in a single antibody molecule (i.e. nipocalimab may be a heterodimer), for example where a heavy chain has undergone C-terminal modifications. Generally, all heavy chains of nipocalimab antibodies comprises at least the sequence of SEQ ID NO: 19.

[0148] In some embodiments, nipocalimab comprises a light chain consisting of the sequence of SEQ ID NO: 1 and a heavy chain comprising a sequence selected from the group consisting of SEQ ID NOs: 19.

[0149] In some embodiments, nipocalimab comprises a mixture of:

[0150] (a) an anti-FcRn antibody that comprises a light chain consisting of the sequence of SEQ ID NO: 1 and a heavy chain consisting of the sequence set forth in SEQ ID NO: 2,

[0151] (b) an anti-FcRn antibody that comprises a light chain consisting of the sequence of SEQ ID NO: 1 and a heavy chain consisting of the sequence set forth in SEQ ID NO: 21; and

[0152] (c) an anti-FcRn antibody that comprises a light chain consisting of the sequence of SEQ ID NO: 1 and a heavy chain consisting of the sequence set forth in SEQ ID NO: 20.

[0153] In some embodiments, the nipocalimab may comprise about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of component (b) and / or may comprise about 0.1-10%, or about 0.1-8%, or about 0.1-5%, or about 0.1-1% of component (c), optionally with the remainder being component (a) (and / or any further variant species of nipocalimab).

[0154] In some embodiments, a nipocalimab formulation may comprise a mixture of anti-FcRn antibodies that each comprise a light chain consisting of the sequence of SEQ ID NO: 1 and collectively comprise:

[0155] (a) heavy chains consisting of the sequence set forth in SEQ ID NO: 2;

[0156] (b) heavy chains consisting of the sequence set forth in SEQ ID NO: 20, wherein the C- terminal proline of SEQ ID NO: 20 may be amidated; and

[0157] (c) heavy chains consisting of the sequence set forth in SEQ ID NO: 21.

[0158] In some embodiments, the nipocalimab formulation may comprise about 90-100%, or about 95-99%, or about 97-99% of component (a), about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of component (b), and about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2%, of component (c) optionally with any remainder being component (a) and / or any further variant species of nipocalimab. In some embodiments, the nipocalimab formulation may comprise about 97-99% of component (a), about 0.5-1.0% of component (b) and about 1-2%, of component (c).

[0159] In some embodiments, about 95-100%, or about 96-99%, or about 97-99% of the heavy chains in the nipocalimab formulation consist of the sequence set forth in SEQ ID NO: 2, about 0.1- 1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the heavy chains in the nipocalimab formulation consist of the sequence set forth in SEQ ID NO: 20, wherein the C-terminal proline of SEQ ID NO: 20 may be amidated, and about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains in the nipocalimab formulation consist of the sequence set forth in SEQ ID NO: 21. In some embodiments, about 97- 99% of the heavy chains in the nipocalimab formulation consist of the sequence set forth in SEQ ID NO: 2, about 0.5-1.0% of the heavy chains in the nipocalimab formulation consist of the sequence set forth in SEQ ID NO: 20, wherein the C-terminal proline of SEQ ID NO: 20 may be amidated, and about 1-2% of the heavy chains in the nipocalimab formulation consist of the sequence set forth in SEQ ID NO: 21.

[0160] In some embodiments, the anti-FcRn antibody comprises or consists of: a light chain comprising or consisting of the sequence:

[0161] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERP SGVSNRFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPS VTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAAS SYLSLTPEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and a heavy chain comprises or consists of the sequence:

[0162] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGS QTRYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG LYSLSSWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTY RWSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG NVFSCSVMHEALHNHYTQKSLSLSPG (SEQ ID NO: 2).

[0163] In some embodiments, the anti-FcRn antibody comprises or consists of: a light chain comprising or consisting of the sequence: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERP

[0164] SGVSNRFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPS VTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAAS SYLSLTPEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and a heavy chain comprises or consists of the sequence:

[0165] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGS QTRYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG LYSLSSWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTY RWSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG NVFSCSVMHEALHNHYTQKSLSLS (SEQ ID NO: 19).

[0166] In some embodiments, the anti-FcRn antibody comprises or consists of: a light chain comprising or consisting of the sequence:

[0167] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERP SGVSNRFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPS VTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAAS SYLSLTPEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and a heavy chain comprises or consists of the sequence:

[0168] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGS QTRYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG LYSLSSWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTY RWSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG NVFSCSVMHEALHNHYTQKSLSLSP (SEQ ID NO: 20), wherein the C-terminal proline may be amidated.

[0169] In some embodiments, the anti-FcRn antibody comprises or consists of: a light chain comprising or consisting of the sequence:

[0170] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERP SGVSNRFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPS VTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAAS SYLSLTPEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and a heavy chain comprises or consists of the sequence: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGS QTRYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG LYSLSSWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSV FLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTY RWSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTK NQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQG NVFSCSVMHEALHNHYTQKSLSLSPGK (SEQ ID NO: 21).

[0171] In some embodiments, the anti-FcRn antibody has: (a) a light chain sequence that is at least 95%, 96%, 97% 98%, or 99% identical to SEQ ID NO: 1, wherein the CDR LI comprises the sequence TGTGSDVGSYNLVS (SEQ ID NO: 3), the CDR L2 comprises the sequence GDSERPS (SEQ ID NO: 4), the CDR L3 comprises the sequence SSYAGSGIYV (SEQ ID NO: 5); and (b) a heavy chain sequence that is at least 95%, 96%, 97% 98%, or 99% identical to SEQ ID NO: 2, wherein the CDR Hl comprises the sequence TYAMG (SEQ ID NO: 6), the CDR H2 comprises the sequence SIGASGSQTRYADS (SEQ ID NO: 7), and the CDR H3 comprises the sequence LAIGDSY (SEQ ID NO: 8).

[0172] In some embodiments, anti-FcRn antibody comprises a heavy chain comprising or consisting of the sequence set forth in SEQ ID NO: 2 with an additional lysine residue at the C- terminus thereof (as in SEQ ID NO: 21). In some embodiments, some or all of the amount of anti- FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, in about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, some or all of the heavy chains of the anti-FcRn antibody further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibody further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, about 1-2% of heavy chains of the anti-FcRn antibody comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21).

[0173] In some embodiments, the anti-FcRn antibody comprises a heavy chain comprising or consisting of the sequence set forth in SEQ ID NO: 2 without the C-terminal glycine (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, some or all of the heavy chains of the anti-FcRn antibody lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments about 0.1-1%, or about 0.2-1.0%, or about 0.3- 1.0%, or about 0.5- 1.0% of the heavy chains of the anti-FcRn antibodies lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, about 1-2% of the heavy chains of the anti-FcRn antibodies lack the glycine residue at the C- terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0174] In some embodiments, about 1-2% of heavy chains of the anti-FcRn antibody comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21) and about 1- 2% of the heavy chains of the anti-FcRn antibodies lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0175] In some embodiments, about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the heavy chains of the anti-FcRn antibody lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19). In some embodiments, about 1-2% of heavy chains of the anti-FcRn antibody lack the proline and glycine residues at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 19).

[0176] In some embodiments, the antibody heavy chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical to SEQ ID NO: 2 with one or more amino acid substitutions. In some embodiments, the antibody light chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical the amino acid sequence of SEQ ID NO: 1 with one or more amino acid substitutions.

[0177] In some embodiments, the antibody heavy chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical to SEQ ID NO: 19 with one or more amino acid substitutions. In some embodiments, the antibody light chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical the amino acid sequence of SEQ ID NO: 1 with one or more amino acid substitutions.

[0178] In some embodiments, the antibody heavy chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical to SEQ ID NO: 20 with one or more amino acid substitutions. In some embodiments, the antibody light chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical the amino acid sequence of SEQ ID NO: 1 with one or more amino acid substitutions. In some embodiments, the antibody heavy chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical to SEQ ID NO: 21 with one or more amino acid substitutions. In some embodiments, the antibody light chain comprises an amino acid sequence at least 95%, 96%, 97% 98%, or 99% identical the amino acid sequence of SEQ ID NO: 1 with one or more amino acid substitutions.

[0179] In some embodiments, the antibody comprising a light chain variable region comprises an amino acid sequence that is at least 95%, 97%, 99%, or 100% identical to: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVL (SEQ ID NO: 9). In some embodiments, the light chain variable region comprises a CDR LI comprising the sequence of TGTGSDVGSYNLVS (SEQ ID NO: 3), a CDR L2 comprising the sequence of GDSERPS (SEQ ID NO: 4), a CDR L3 comprising the sequence of SSYAGSGIYV (SEQ ID NO: 5). In some embodiments, the antibody comprises a heavy chain variable region comprising an amino acid sequence that is at least 95%, 97%, 99%, or 100% identical to:

[0180] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFT1SRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSS (SEQ ID NO: 10). In some embodiments, the heavy chain variable region comprises a CDR Hl comprising the sequence of TYAMG (SEQ ID NO: 6), a CDR H2 comprising the sequence of SIGASGSQTRYADS (SEQ ID NO: 7), and a CDR H3 comprising the sequence of LAIGDSY (SEQ ID NO: 8).

[0181] The antibodies may further comprise amino acid substitutions, additions, and / or deletions outside of the CDRs (i.e., in framework regions (FRs)). In some embodiments, the amino acid substitution, addition, and / or deletion is a substitution, addition, and / or deletion of one or more amino acids (e.g., 1, 2, 3, 4, 5, 6, 7, 8, or more). In some embodiments, an amino acid substitution, addition, and / or deletion is a substitution, addition, and / or deletion of eight or fewer, seven or fewer, six or fewer, five or fewer, four or fewer, three or fewer, or two or fewer single amino acids.

[0182] In some embodiments, the antibodies may include amino acid substitutions, additions, and / or deletions in the constant regions (e.g., Fc region) of the antibody that, e.g., lead to decreased effector function, e.g., decreased complement-dependent cytolysis (CDC), antibody-dependent cell- mediated cytolysis (ADCC), and / or antibody-dependent cell-mediated phagocytosis (ADCP), and / or decreased B-cell killing. The constant regions are not involved directly in binding an antibody to its target, but exhibit various effector functions, such as participation of the antibody in antibody-dependent cellular toxicity. In some embodiments, the antibodies are characterized by decreased binding (i.e., absence of binding) to human complement factor Clq and / or human Fc receptor on natural killer (NK) cells. In some embodiments, the antibodies are characterized by decreased binding (i.e., absence of binding) to human FcyRI, FcyRIIA, and / or FcyRIIIA. To alter or reduce an antibody-dependent effector function, such as CDC, ADCC, ADCP, and / or B-cell killing, antibodies may be of the IgG class and contain one or more amino acid substitutions E233, L234, G236, D265, D270, N297, E318, K320, K322, A327, A330, P331, and / or P329 (numbering according to the EU System). The resulting effectorless antibody shows very little binding to complement or Fc receptors (i.e., complement Clq binding), indicating low CDC potential.

[0183] In some embodiments, the isolated antibody comprises a CDR LI comprising the sequence of TGTGSDVGSYNLVS (SEQ ID NO: 3), a CDR L2 comprising the sequence of GDSERPS (SEQ ID NO: 4), a CDR L3 comprising the sequence of SSYAGSGIYV (SEQ ID NO: 5), a CDR Hl comprising the sequence of NYAMG (SEQ ID NO: 11), a CDR H2 comprising the sequence of SIGASGAQTRYADS (SEQ ID NO: 12), and a CDR H3 comprising the sequence of LAIGDSY (SEQ ID NO: 8).

[0184] In some embodiments, the isolated antibody comprises a CDR LI comprising the sequence of TGTGSDVGSYNLVS (SEQ ID NO: 3), a CDR L2 comprising the sequence of GDSERPS (SEQ ID NO: 4), a CDR L3 comprising the sequence of SSYAGSGIYV (SEQ ID NO: 5), a CDR Hl comprising the sequence of TYAMG (SEQ ID NO: 6), a CDR H2 comprising the sequence of SIGASGGQTRYADS (SEQ ID NO: 12), and a CDR H3 comprising the sequence of LAIGDSY (SEQ ID NO: 8).

[0185] In some embodiments, the isolated antibody comprises a CDR LI comprising the sequence of TGTGSDVGSYNLVS (SEQ ID NO: 3), a CDR L2 comprising the sequence of GDSERPS (SEQ ID NO: 4), a CDR L3 comprising the sequence of SSYAGSGIYV (SEQ ID NO: 5), a CDR Hl comprising the sequence of TYAMG (SEQ ID NO: 6), a CDRH2 comprising the sequence of SIGS SGAQTRY ADS (SEQ ID NO: 17), and a CDR H3 comprising the sequence of LAIGDSY (SEQ ID NO: 8).

[0186] In some embodiments, the isolated antibody comprises a CDR LI comprising the sequence of TGTGSDVGSYNLVS (SEQ ID NO: 3), a CDR L2 comprising the sequence of GDSERPS (SEQ ID NO: 4), a CDR L3 comprising the sequence of SSYAGSGIYV (SEQ ID NO: 5), a CDR Hl comprising the sequence of DYAMG (SEQ ID NO: 18), a CDR H2 comprising the sequence of SIGASGSQTRYADS (SEQ ID NO: 7), and a CDR H3 comprising the sequence of LAIGDSY (SEQ ID NO: 8).

[0187] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises a sequence having the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and wherein the heavy chain comprises a sequence having the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 2).

[0188] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having the sequence as set forth in SEQ ID NO: 2 with an additional lysine (K) residue at the C-terminus thereof (as in SEQ ID NO: 21). In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0189] In some embodiments, the light chain of the isolated antibody comprises a sequence having at least 90% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1).

[0190] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 90% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 2).

[0191] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90% identity to the sequence as set forth in SEQ ID NO: 2, with an additional lysine (K) residue at the C-terminus thereof (as in SEQ ID NO: 21). In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C- terminal proline may be amidated.

[0192] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 90% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGSSGAQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 13).

[0193] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90% identity to the sequence as set forth in SEQ ID NO: 13, with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 13 and the resulting C-terminal proline may be amidated.

[0194] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 90% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSDYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFT1SRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 14). In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90% identity to the sequence as set forth in SEQ ID NO:

[0195] 14, with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 14 and the resulting C-terminal proline may be amidated.

[0196] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 90% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSNYAMGWVRQAPGKGLEWVSSIGASGAQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 15).

[0197] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90% identity to the sequence as set forth in SEQ ID NO:

[0198] 15, with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 15 and the resulting C-terminal proline may be amidated.

[0199] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 90% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGGQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 16).

[0200] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90% identity to the sequence as set forth in SEQ ID NO:

[0201] 16, with an additional lysine (K) residue at the C-terminal thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 16 and the resulting C-terminal proline may be amidated.

[0202] In some embodiments, the isolated antibody has a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of:

[0203] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 2).

[0204] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence as set forth in SEQ ID NO: 2 (as in SEQ ID NO: 21), with an additional lysine (K) residue at the C- terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0205] In some embodiments, the isolated antibody has a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of:

[0206] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY

[0207] ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLS (SEQ ID NO: 19).

[0208] In some embodiments, the isolated antibody has a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of:

[0209] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSP (SEQ ID NO: 20).

[0210] In some embodiments, the isolated antibody has a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of:

[0211] EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPGK (SEQ ID NO: 21).

[0212] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGSSGAQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 13).

[0213] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence as set forth in SEQ ID NO: 13, with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 13 and the resulting C-terminal proline may be amidated.

[0214] In some embodiments, the isolated antibody containing comprises a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSDYAMGWVRQAPGKGLEWVSSIGASGSQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 14).

[0215] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence as set forth in SEQ ID NO: 14, with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 14 and the resulting C-terminal proline may be amidated.

[0216] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSNYAMGWVRQAPGKGLEWVSSIGASGAQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 15). In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence as set forth in SEQ ID NO: 15, with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 15 and the resulting C-terminal proline may be amidated.

[0217] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGGQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 16).

[0218] In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain comprises a sequence having at least 90%, 95%, 98% or 99% identity to the sequence as set forth in SEQ ID NO: 16, with an additional lysine (K) residue a the C-terminus thereof. In some embodiments, the isolated antibody comprises a heavy chain, wherein the heavy chain lacks the glycine residue at the C-terminus of SEQ ID NO: 16 and the resulting C-terminal proline may be amidated.

[0219] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 95%, 97%, 99%, or 100% identity to the sequence of any one of SEQ ID NOs: 2, 13-16, 19- 21. In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 95%, 97%, 99%, or 100% identity to the sequence of any one of SEQ ID NOs: 2, 13-16 with an additional lysine (K) residue at the C-terminus thereof. In some embodiments, the heavy chain of the isolated antibody comprises a sequence having at least 95%, 97%, 99%, or 100% identity to the sequence of any one of SEQ ID NOs: 2, 13-16, wherein the heavy chain lacks the C-terminal glycine (G) and wherein the resulting C-terminal proline may be amidated. In some embodiments, the light chain of the isolated antibody comprises a sequence having at least 95%, 97%, 99%, or 100% identity to the sequence of SEQ ID NO: 1.

[0220] In some embodiments, the heavy chain of the isolated antibody comprises a sequence having no more than 5, 4, 3, 2 or 1 single amino acid substitutions relative to the amino acid sequence of any one of SEQ ID NO: 2. In some embodiments, the heavy chain of the isolated antibody comprises a sequence having no more than 5, 4, 3, 2 or 1 single amino acid substitutions relative to the amino acid sequence of any one of SEQ ID NO: 2, 13-16 with an additional lysine (K) residue at the C-terminus thereof, and the light chain of the isolated antibody comprises a sequence having no more than 5, 4, 3, 2 or 1 single amino acid substitutions relative to the sequence of SEQ ID NO: 1. In some embodiments, the heavy chain of the isolated antibody comprises a sequence having no more than 5, 4, 3, 2 or 1 single amino acid substitutions relative to the amino acid sequence of any one of SEQ ID NO: 2, 13-16 wherein the heavy chain lacks the C-terminal glycine (G) and wherein the resulting C-terminal proline may be amidated, and the light chain of the isolated antibody comprises a sequence having no more than 5, 4, 3, 2 or 1 single amino acid substitutions relative to the sequence of SEQ ID NO: 1.

[0221] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises or consists of the sequence of:

[0222] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and wherein the heavy chain comprises or consists of the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGSSGAQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 13).

[0223] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises or consists of the sequence of:

[0224] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN

[0225] RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP

[0226] SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT

[0227] PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and wherein the heavy chain comprises or consists of the sequence of:

[0228] EVQLLESGGGLVQPGGSLRLSCAASGFTFSDYAMGWVRQAPGKGLEWVSSIGASGSQTRY

[0229] ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK

[0230] GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS

[0231] VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 14).

[0232] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises the sequence of:

[0233] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN

[0234] RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP

[0235] SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT

[0236] PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and wherein the heavy chain comprises or consists of the sequence of:

[0237] EVQLLESGGGLVQPGGSLRLSCAASGFTFSNYAMGWVRQAPGKGLEWVSSIGASGAQTRY

[0238] ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK

[0239] GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS

[0240] VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 15).

[0241] In some embodiments, the isolated antibody comprises a light chain and a heavy chain, wherein the light chain comprises or consists of the sequence of:

[0242] QSALTQPASVSGSPGQSITISCTGTGSDVGSYNLVSWYQQHPGKAPKLMIYGDSERPSGVSN

[0243] RFSGSKSGNTASLTISGLQAEDEADYYCSSYAGSGIYVFGTGTKVTVLGQPKAAPSVTLFPP SSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLT PEQWKSHKSYSCQVTHEGSTVEKTVAPTECS (SEQ ID NO: 1); and wherein the heavy chain comprises or consists of the sequence of: EVQLLESGGGLVQPGGSLRLSCAASGFTFSTYAMGWVRQAPGKGLEWVSSIGASGGQTRY ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARLAIGDSYWGQGTMVTVSSASTK GPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLS SWTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPP KPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVS VLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSL TCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPG (SEQ ID NO: 16).

[0244] Without being bound by any particular theory, it is believed that the anti-FcRn antibodies compete with and inhibit the binding of IgG to human FcRn. Epitope mapping by hydrogendeuterium exchange of the antibodies provided herein indicates that the antibodies bind to an epitope on FcRn located in and / or adjacent to the Fc-FcRn interaction interface, which suggests that the antibodies block IgG binding to FcRn by direct inhibition. Furthermore, the epitope-mapped binding site is distant from the albumin-binding site of FcRn. Accordingly, serum albumin-binding should not be inhibited and serum albumin levels should not be reduced more than about 35%, 30% or 25% below baseline (e.g., normal levels of serum albumin).

[0245] In some embodiments, the anti-FcRn antibody is nipocalimab, RVT-1401 (HL161), rozanolixizumab (UCB7665), ALXN1830, ABY-039, or efgartigimod. RVT-1401 (also referred to as HL161BKN) is described in W02020097099, rozanolixizumab is described in WO2014019727, and efgartigimod (ARGX-113) is described in WO2015100299, each of which is hereby incorporated by reference in its entirety. In some embodiments, the anti-FcRn antibody is a biosimilar of any of anti-FcRn antibodies provided for herein. In some embodiments, the anti-FcRn antibody is nipocalimab. In some embodiments, the anti-FcRn antibody is RVT-1401 (HL161). In some embodiments, the anti-FcRn antibody is rozanolixizumab (UCB7665). In some embodiments, the anti-FcRn antibody is ALXN1830. In some embodiments, the anti-FcRn antibody is ABY-039. In some embodiments, the anti-FcRn antibody is efgartigimod. In preferred embodiments, the anti- FcRn antibody is nipocalimab.

[0246] In some embodiments, the Fc domain of the antibody is not fucosylated. In some embodiments of all the methods described herein, the Fc domain of the antibody is not glycosylated.

[0247] In some embodiments, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2. In some embodiments, the anti-FcRn antibody comprises a heavy chain of SEQ ID NO: 2 with an additional lysine residue attached at the end of the C- terminus.

[0248] FcRn inhibition

[0249] FcRn is a type I transmembrane protein that functions as an IgG- and serum albuminbinding, intracellular vesicular trafficking protein. FcRn is expressed in endothelial cells, luminal epithelial cells, hepatocytes, podocytes, granulocytes, monocytes, macrophages, dendritic cells, and NK cells, but not on B or T cells. FcRn maintains the half-life of IgG by binding and trafficking constitutively internalized IgG back to the cell surface. Binding of both Fc and serum albumin by FcRn occurs in the early endosome at pH 6.0, followed by sorting of the FcRn into vesicles, which traffic the FcRn-bound IgG or albumin back to the cell surface where FcRn rapidly releases the IgG or albumin at pH 7.4. This trafficking cycle maintains the half-life of IgG and albumin by recycling both into the circulation and preventing trafficking to the lysosomes for degradation. FcRn also captures internalized IgG Fc in epithelial cells and transports them bidirectionally to the opposing apical or basolateral membranes. This function allows IgG to traffic to the lumen of organs such as the gastrointestinal tract or the transport of IgG or IgG-antigen complexes from the lumen to the vasculature or lymphoid tissues in the stromal layers.

[0250] In order to study the contribution of FcRn to IgG homeostasis, mice have been engineered so that parts of the light and heavy chains of FcRn have been “knocked out” so that these proteins are not expressed (Junghans et al., Proc Natl Acad Sci USA 93:5512, 1996, which is hereby incorporated by reference in its entirety). In these mice, the serum half-life and concentrations of IgG were dramatically reduced, suggesting an FcRn-dependent mechanism of IgG homeostasis. Studies in rodent models, such as the one discussed above, suggest that blockage of FcRn can increase IgG catabolism, including that of pathogenic autoantibodies, thereby inhibiting disease (e.g., an autoimmune disease) development. FcRn may also contribute to antigen presentation through trafficking of immune complexes to antigen degradation and MHC loading compartments.

[0251] The present disclosure provides isolated anti-FcRn antibodies that bind to human FcRn with high affinity. The anti-FcRn antibodies compete with and effectively inhibit the binding of other anti-FcRn antibodies (e.g., IgG, IgG autoantibodies) to FcRn, thereby increasing the catabolism and decreasing the half-life of other anti-FcRn antibodies (e.g., IgG, IgG autoantibodies). The anti-FcRn antibodies may be used in a method of treating or reducing immune complex-based activation of an immune response in a subject, such as an immune response caused by autoantibodies in an autoimmune disease. Placental transfer of maternal IgG antibodies to the fetus is an important FcRn-dependent mechanism that provides protection to the neonate while his / her humoral response is inefficient. During fetal life, FcRn in the syncytiotrophoblast layers of the placenta is responsible for the transfer of maternal IgG antibodies to the fetus. Pathogenic maternal antibodies (e.g., pathogenic maternal IgG antibodies) may also cross the placenta by binding to FcRn and cause alloimmune disorders and / or autoimmune disorders in the fetus and neonate. In some embodiments, pathogenic antibodies in the pregnant subject cause a fetal and neonatal alloimmune and / or autoimmune disorder in a fetus in the pregnant subject. The anti-FcRn antibodies described herein may compete with and inhibit the binding of maternal pathogenic antibodies (e.g., maternal pathogenic IgG antibodies) to FcRn, thereby increasing the catabolism and decreasing the half-life of these pathogenic antibodies.

[0252] The present disclosure provides isolated anti-FcRn antibodies that bind to human FcRn. The anti-FcRn antibodies may compete with and inhibit the binding of other anti-FcRn antibodies (e.g., IgG, IgG autoantibodies) to FcRn, thereby increasing the catabolism and decreasing the half-life of other anti-FcRn antibodies (e.g., IgG, IgG autoantibodies). The anti-FcRn antibodies may be used in a method of treating or reducing immune complex-based activation of an immune response in a subject, such as an immune response caused by autoantibodies in an autoimmune disease. Reducing an immune response may be described as reducing an immune response relative to a subject who does not receive treatment (e.g., a control subject). The anti-FcRn antibodies may also be used in methods of decreasing pathogenic antibody transport (e.g., pathogenic maternal IgG antibody transport) across the placenta of a pregnant subject, increasing pathogenic antibody catabolism in a pregnant subject, and treating an antibody-mediated enhancement of viral disease in a fetus or a neonate by administering to a pregnant subject an isolated antibody that binds to human FcRn. Decreasing pathogenic antibody transport across the placenta of a pregnant subject, may be described as decreasing pathogenic antibody transport relative to a subject who does not receive treatment (e.g., a control subject). In another aspect, the present disclosure features a method of treating an antibody-mediated enhancement of viral disease in a fetus or a neonate, the method comprising, consisting of, or consisting essentially of administering an antibody described herein to a pregnant subject, wherein the antibody comprises, consists of, or consists essentially of: a light chain and a heavy chain, wherein the light chain comprises, consists of, or consists essentially of the sequence of SEQ ID NO: 1; and the heavy chain comprises, consists of, or consists essentially of the sequence of SEQ ID NO: 2. In another aspect, the present disclosure features a method of treating an antibody-mediated enhancement of viral disease in a fetus or a neonate, the method comprising, consisting of, or consisting essentially of administering an antibody to a pregnant subject, wherein the antibody comprises, consists of, or consists essentially of: a light chain and a heavy chain, wherein the light chain comprises, consists of, or consists essentially of a sequence having at least 90%, 95%, 96%, 97%, 98%, 99% or 100% identity to the sequence of SEQ ID NO: 1 ; and the heavy chain comprises, consists of, or consists essentially of a sequence having at least 90%, 95%, 96%, 97%, 98%, 99% or 100% identity to the sequence of SEQ ID NO: 2.

[0253] Vectors, host cells, and antibody production

[0254] The anti-FcRn antibodies can be produced from a host cell. A host cell refers to a vehicle that includes the necessary cellular components, e.g., organelles, needed to express the polypeptides and constructs described herein from their corresponding nucleic acids. The nucleic acids may be included in nucleic acid vectors that can be introduced into the host cell by conventional techniques known in the art (e.g., transformation, transfection, electroporation, calcium phosphate precipitation, direct microinjection, infection, etc.). The choice of nucleic acid vectors depends in part on the host cells to be used. Generally, host cells are of either prokaryotic (e.g., bacterial) or eukaryotic (e.g., mammalian) origin.

[0255] Nucleic acid vector construction and host cells

[0256] A nucleic acid sequence encoding the amino acid sequence of an anti-FcRn antibody may be prepared by a variety of methods known in the art. These methods include, but are not limited to, oligonucleotide -mediated (or site-directed) mutagenesis and PCR mutagenesis. A nucleic acid molecule encoding an anti-FcRn antibody may be obtained using standard techniques, e.g., gene synthesis. Alternatively, a nucleic acid molecule encoding a wild-type anti-FcRn antibody may be mutated to contain specific amino acid substitutions using standard techniques in the art, e.g., QuikChange™ mutagenesis. Nucleic acid molecules can be synthesized using a nucleotide synthesizer or PCR techniques.

[0257] Nucleic acid sequences encoding anti-FcRn antibodies may be inserted into a vector capable of replicating and expressing the nucleic acid molecules in prokaryotic or eukaryotic host cells. Many vectors are available in the art and can be used for the purpose of the disclosure. Each vector may contain various components that may be adjusted and optimized for compatibility with the particular host cell. For example, the vector components may include, but are not limited to, an origin of replication, a selection marker gene, a promoter, a ribosome binding site, a signal sequence, the nucleic acid sequence encoding protein of interest, and a transcription termination sequence. In some embodiments, mammalian cells are used as host cells for the disclosure. Examples of mammalian cell types include, but are not limited to, human embryonic kidney (HEK) (e.g., HEK293, HEK 293F), Chinese hamster ovary (CHO), HeLa, COS, PC3, Vero, MC3T3, NSO, Sp2 / 0, VERY, BHK, MDCK, W138, BT483, Hs578T, HTB2, BT20, T47D, NSO (a murine myeloma cell line that does not endogenously produce any immunoglobulin chains), CRL7O3O, and HsS78Bst cells. In other embodiments, E. coli cells are used as host cells for the disclosure. Examples of E. coli strains include, but are not limited to, E. coli 294 (ATCC® 31,446), E. coli X 1776 (ATCC® 31,537, E. coli BL21 (DE3) (ATCC® BAA- 1025), and E. coli RV308 (ATCC® 31,608). Different host cells have characteristic and specific mechanisms for the posttranslational processing and modification of protein products. Appropriate cell lines or host systems may be chosen to ensure the correct modification and processing of the anti-FcRn antibody expressed. The above-described expression vectors may be introduced into appropriate host cells using conventional techniques in the art, e.g., transformation, transfection, electroporation, calcium phosphate precipitation, and direct microinjection. Once the vectors are introduced into host cells for protein production, host cells are cultured in conventional nutrient media modified as appropriate for inducing promoters, selecting transformants, or amplifying the genes encoding the desired sequences. Methods for expression of therapeutic proteins are known in the art, see, for example, Paulina Baibas, Argelia Lorence (eds.) Recombinant Gene Expression: Reviews and Protocols (Methods in Molecular Biology), Humana Press; 2nd ed. 2004 (July 20, 2004) and Vladimir Voynov and Justin A. Caravella (eds.) Therapeutic Proteins: Methods and Protocols (Methods in Molecular Biology) Humana Press; 2nd ed. 2012 (June 28, 2012).

[0258] Protein production, recovery, and purification

[0259] Host cells used to produce the anti-FcRn antibodies may be grown in media known in the art and suitable for culturing of the selected host cells. Examples of suitable media for mammalian host cells include Minimal Essential Medium (MEM), Dulbecco’s Modified Eagle’s Medium (DMEM), Expi293™ Expression Medium, DMEM with supplemented fetal bovine serum (FBS), and RPMI- 1640. Examples of suitable media for bacterial host cells include Luria broth (LB) plus necessary supplements, such as a selection agent, e.g., ampicillin. Host cells are cultured at suitable temperatures, such as from about 20 °C to about 39 °C, e.g., from 25 °C to about 37 °C, about 37 °C, and CO2 levels, such as 5 to 10% (about 8%). The pH of the medium is generally from about 6.8 to 7.4, e.g., 7.0, depending mainly on the host organism. If an inducible promoter is used in the expression vector of the disclosure, protein expression is induced under conditions suitable for the activation of the promoter. Protein recovery typically involves disrupting the host cell, generally by such means as osmotic shock, sonication, or lysis. Once the cells are disrupted, cell debris may be removed by centrifugation or filtration. The proteins may be further purified. An anti-FcRn antibody may be purified by any method known in the art of protein purification, for example, by protein A affinity, other chromatography (e.g., ion exchange, affinity, and size-exclusion column chromatography), centrifugation, differential solubility, or by any other standard technique for the purification of proteins. In some instances, an anti-FcRn antibody can be conjugated to marker sequences, such as a peptide to facilitate purification. An example of a marker amino acid sequence is a hexa-histidine peptide (His-tag), which binds to nickel-functionalized agarose affinity column with micromolar affinity. Other peptide tags useful for purification include, but are not limited to, the hemagglutinin “HA” tag, which corresponds to an epitope derived from the influenza hemagglutinin protein. In some embodiments, the purified anti-FcRn antibody comprises a heavy chain comprising a C- terminal lysine. In some embodiments, the purified anti-FcRn antibody comprises a heavy chain that does not comprise a C-terminal lysine. In some embodiments, the purified anti-FcRn antibody comprises a population of purified anti-FcRn antibodies, wherein the population of anti-FcRn antibodies comprises a population of heavy chains that comprise a C-terminal lysine, and a population of heavy chains that do not comprise a C-terminal lysine.

[0260] Pharmaceutical compositions and preparations

[0261] The disclosure features pharmaceutical compositions that include one or more anti-FcRn antibodies described herein. In addition to a therapeutically effective amount of the antibody, the pharmaceutical compositions may contain one or more pharmaceutically acceptable carriers or excipients, which can be formulated by methods known to those skilled in the art.

[0262] Acceptable carriers and excipients in the pharmaceutical compositions are nontoxic to recipients at the dosages and concentrations employed. Acceptable carriers and excipients may include buffers, antioxidants, preservatives, polymers, amino acids, and carbohydrates. Pharmaceutical compositions can be administered parenterally in the form of an injectable formulation. Pharmaceutical compositions for injection can be formulated using a sterile solution or any pharmaceutically acceptable liquid as a vehicle. Pharmaceutically acceptable vehicles include, but are not limited to, sterile water, physiological saline, and cell culture media (e.g., Dulbecco’s Modified Eagle Medium (DMEM), a-Modified Eagles Medium (a-MEM), F-12 medium). Formulation methods are known in the art, see e.g., Banga (ed.) Therapeutic Peptides and Proteins: Formulation, Processing and Delivery Systems (2nd ed.) Taylor & Francis Group, CRC Press (2006), which is hereby incorporated by reference in its entirety. In some embodiments, the composition is administered parenterally. In some embodiments, the composition is administered intravenously or subcutaneously. In some embodiments, the composition is administered intraperitoneal, intradermally, or intramuscularly. In some embodiments, the composition is administered intravenously. In some embodiments, the composition is administered subcutaneously. In some embodiments, the composition is administered using an infusion pump. In some embodiments, the composition is administered using an autoinjector. In some embodiments, the composition is administered using a patch pump injector. In some embodiments, the composition is administered using a wearable injector. In some embodiments, the composition is administered using a Sorrel™ pump. In some embodiments, the composition is administered using a pump, such as those in U.S. Patent No. 9,943,642, which is hereby incorporated in its entirety. In some embodiments, the composition is administered using an on-body delivery system (OBDS).

[0263] Pharmaceutical compositions that contain one or more anti-FcRn antibodies as the therapeutic proteins may be formulated for intravenous or subcutaneous administration. In preferred embodiments, the pharmaceutical composition comprises nipocalimab.

[0264] Throughout the present disclosure, all expressions of percentage, ratio, and the like are "by weight" unless otherwise indicated. As used herein, "by weight" is synonymous with the term "by mass," and indicates that a ratio or percentage defined herein is done according to weight rather than volume, thickness, or some other measure.

[0265] The present disclosure is directed to anti-FcRn antibody compositions.

[0266] As described herein, the term "anti-FcRn antibody composition" refers to a composition comprising one or more anti-FcRn antibodies, or one or more antibody fragments thereof.

[0267] In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at an amount of from about 1 mg / ml to about 500 mg / ml, about 1 mg / mL to about 250 mg / mL, about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL. In some embodiments, the anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at an amount of about 5 mg / mL, about 10 mg / mL, about 15 mg / mL, about 20 mg / mL, about 25 mg / mL, about 30 mg / mL, about 40 mg / mL, about 45 mg / mL, about 50 mg / mL, about 55 mg / mL, about 60 mg / mL, about 65 mg / mL, about 70 mg / mL, about 75 mg / mL, about 80 mg / mL, about 85 mg / mL, about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about 215 mg / mL, about 220 mg / mL, about 225 mg / mL, about 230 mg / mL, about 235 mg / mL, about 240 mg / mL, about 245 mg / mL, about 250 mg / mL, about 255 mg / mL, about 260 mg / mL, about 265 mg / mL, about 270 mg / mL, about 275 mg / mL, about 280 mg / mL, about 285 mg / mL, about 290 mg / mL, about 295 mg / mL, about 300 mg / mL, about 350 mg / mL, about 400 mg / mL, about 450 mg / mL, or about 500 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at an amount of about 50 mg / mL to about 250 mg / mL. In some embodiments, an anti- FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at an amount of about 100 mg / mL to about 250 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at an amount of about 185 mg / mL to about 230 mg / mL.

[0268] In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 25 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 50 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 75 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 80 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 85 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 90 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 95 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 100 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 105 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 110 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 115 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 120 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 125 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 130 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 135 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 140 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 145 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 150 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 155 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 160 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 165 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 170 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 175 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 180 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 185 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 190 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 195 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 200 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 205 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 210 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 215 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 220 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 225 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 230 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 235 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 240 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 245 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 250 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 255 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 260 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 265 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 270 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 275 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 280 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 285 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 290 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 295 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 300 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 350 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 400 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 450 mg / mL. In some embodiments, an anti-FcRn antibody, or antibody fragment thereof, is present in the pharmaceutical composition at about 500 mg / mL.

[0269] In some embodiments, nipocalimab is present in the pharmaceutical composition at an amount of from about 1 mg / mL to about 500 mg / mL, about 1 mg / mL to about 250 mg / mL, about 50 mg / mL to about 250 mg / mL, about 100 mg / mL to about 250 mg / mL, about 150 mg / mL to about 250 mg / mL or, about 185 mg / mL to about 230 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at an amount of about 5 mg / mL, about 10 mg / mL, about 15 mg / mL, about 20 mg / mL, about 25 mg / mL, about 30 mg / mL, about 40 mg / mL, about 45 mg / mL, about 50 mg / mL, about 55 mg / mL, about 60 mg / mL, about 65 mg / mL, about 70 mg / mL, about 75 mg / mL, about 80 mg / mL, about 85 mg / mL, about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about 215 mg / mL, about 220 mg / mL, about 225 mg / mL, about 230 mg / mL, about 235 mg / mL, about 240 mg / mL, about 245 mg / mL, about 250 mg / mL, about 255 mg / mL, about 260 mg / mL, about 265 mg / mL, about 270 mg / mL, about 275 mg / mL, about 280 mg / mL, about 285 mg / mL, about 290 mg / mL, about 295 mg / mL, about 300 mg / mL, about 350 mg / mL, about 400 mg / mL, about 450 mg / mL, or about 500 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at an amount of about 150 mg / ml to about 250 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at an amount of about 185 mg / ml to about 230 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at an amount of about 50 mg / ml to about 250 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at an amount of about 100 mg / ml to about 250 mg / mL.

[0270] In some embodiments, nipocalimab is present in the pharmaceutical composition at about 25 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 50 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 75 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 80 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 85 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 90 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 95 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 100 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 105 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 110 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 115 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 120 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 125 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 130 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 135 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 140 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 145 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 150 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 155 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 160 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 165 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 170 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 175 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 180 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 185 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 190 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 195 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 200 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 205 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 210 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 215 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 220 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 225 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 230 v. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 235 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 240 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 245 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 250 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 255 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 260 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 265 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 270 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 275 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 280 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 285 mg / mL 1. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 290 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 295 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 300 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 350 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 400 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 450 mg / mL. In some embodiments, nipocalimab is present in the pharmaceutical composition at about 500 mg / mL.

[0271] In some embodiments, the pharmaceutical composition comprises a buffer (e.g., histidine, acetate, phosphate or citrate buffer) and / or a stabilizer agent (e.g. human albumin), etc., or a combination thereof. In some embodiments, the pharmaceutical composition comprises one or more pharmaceutically acceptable carriers, including, e.g., ion exchangers, alumina, aluminum stearate, lecithin, serum proteins, such as human serum albumin, buffer substances such as phosphates, sucrose, glycine, sorbic acid, potassium sorbate, partial glyceride mixtures of saturated vegetable fatty acids, water, salts or electrolytes, such as protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salts, colloidal silica, magnesium trisilicate, polyvinyl pyrrolidone, cellulose- based substances, polyethylene glycol, sodium carboxymethylcellulose, polyacrylates, polyethylene-polyoxypropylene-block polymers, and polyethylene glycol, or a combination thereof.

[0272] Various buffers can be present in the anti-FcRn antibody composition of the present disclosure. In some embodiments, the buffer is a histidine buffer, a histidine HC1 buffer, a glycine buffer, a Tris / glycine buffer, an acetate buffer, a sodium acetate buffer, a potassium acetate buffer, a magnesium acetate buffer, a phosphate buffer, a citrate buffer, or a succinate buffer. In some embodiments, the buffer is a histidine buffer. In some embodiments, the buffer is a histidine HC1 buffer. In some embodiments, the buffer is a glycine buffer. In some embodiments, the buffer is a Tris / glycine buffer. In some embodiments, the buffer is an acetate buffer. In some embodiments, the buffer is a sodium acetate buffer. In some embodiments, the buffer is a potassium acetate buffer. In some embodiments, the buffer is a magnesium acetate buffer. In some embodiments, the buffer is a phosphate buffer. In some embodiments, the buffer is a citrate buffer. In some embodiments, the buffer is a succinate buffer. In preferred embodiments, the buffer is a histidine buffer.

[0273] In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise a histidine buffer. In some embodiments, pharmaceutical compositions of nipocalimab comprise a histidine buffer. In some embodiments, the pharmaceutical composition comprises from about 1 mM to about 100 mM histidine buffer, for example, from about 1 mM to about 80 mM histidine buffer, from about 1 mM to about 60 mM histidine buffer, from about 1 mM to about 50 mM histidine buffer, from about 1 mM to about 30 mM histidine buffer, from about 1 mM to about 20 mM histidine buffer, or about 10 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 1 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 2 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 3 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 4 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 5 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 6 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 7 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 8 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 9 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 10 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 11 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 12 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 13 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 14 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 15 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 16 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 17 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 18 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 19 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 20 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 25 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 30 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 35 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 40 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 45 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 50 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 55 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 60 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 65 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 70 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 75 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 80 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 85 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 90 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 95 mM histidine buffer. In some embodiments, the pharmaceutical composition comprises about 100 mM histidine buffer.

[0274] In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise an uncharged excipient. The term "excipient" refers to a pharmacologically inactive substance formulated with an antibody or antibody fragment thereof as described herein. In some aspects, the uncharged excipient can assist in the prevention of denaturation or otherwise assist in stabilizing the antibody or antibody fragment thereof. Examples of excipients are known in the art. Examples can be taken, e.g., from the handbook: Gennaro, Alfonso R.: "Remington's Pharmaceutical Sciences", Mack Publishing Company, Easton, Pa., 1990, which is hereby incorporated by reference in its entirety.

[0275] In some embodiments, the uncharged excipient is a polyol, fructose, glucose, mannose, sorbose, xylose, lactose, maltose, sucrose, dextran, pullulan, dextrin, cyclodextrins, soluble starch, trehalose, sorbitol, erythritol, isomalt, lactitol, maltitol, xylitol, glycerol, lactitol, hydroxyethyl starch, water-soluble glucans, or a combination thereof. In some embodiments, the uncharged excipient is sucrose. In some embodiments, the uncharged excipient is trehaolse. In some embodiments, the uncharged excipient is mannitol.

[0276] In some embodiments, the uncharged excipient is present in the anti-FcRn antibody pharmaceutical composition in an amount of from 0.5% (w / v) to about 20% (w / v), for example, from about 0.5% to about 20%, from about 1% to about 20%, from about 1% to about 15%, from about 1% to about 10%, from about 2% to about 10%, from about 3% to about 10%, from about 3% to about 9%, or from about 3% to about 9%. In some embodiments the uncharged excipient is present at an amount of about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, about 4.5%, about 5%, about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%, about 10.5%, about 11%, about 11.5%, about 12%, about 12.5%, about 13%, about 13.5%, about 14%, about 14.5%, about 15%, about 15.5%, about 16%, about 16.5%, about 17%, about 17.5%, about 18%, about 18.5%, about 19%, about 19.5%, or about 20% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4%, 4.1%,

[0277] 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%, 5.6%,

[0278] 5.7%, 5.8%, 5.9%, 6%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9%, 7%, 7.1%, 7.2%,

[0279] 7.3%, 7.4%, 7.5%, 7.6%, 7.7%, 7.8%, 7.9%, 8%, 8.1%, 8.2%, 8.3%, 8.4%, 8.5%, 8.6%, 8.7%,

[0280] 8.8%, 8.9%, 9%, 9.1%, 9.2%, 9.3%, 9.4%, 9.5%, 9.6%, 9.7%, 9.8%, 9.9%, or 10%. (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.5%, about 6.4%, or about 8%. In some embodiments, the uncharged excipient is present in the pharmaceutical composition at an amount of about 1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 1.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 2.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 3.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 4.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 5.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 6.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 7.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 8.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.1% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.2% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.3% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.4% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.5% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.6% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.7% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.8% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 9.9% (w / v). In some embodiments, the uncharged excipient is present at an amount of about 10% (w / v).

[0281] In some embodiments, the uncharged excipient is sucrose. In some embodiments, sucrose is present in the anti-FcRn antibody pharmaceutical composition in an amount of from 0.5% (w / v) to about 20% (w / v), for example, from about 0.5% to about 20%, from about 1% to about 20%, from about 1% to about 15%, from about 1% to about 10%, from about 2% to about 10%, from about 3% to about 10%, from about 3% to about 9%, or from about 3% to about 8%. In some embodiments sucrose is present at an amount of about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% (w / v). In some embodiments, sucrose is present in the pharmaceutical composition at an amount of about 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3%, 3.1%, 3.2%, 3.3%,

[0282] 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%,

[0283] 4.9%, 5%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%, 5.6%, 5.7%, 5.8%, 5.9%, 6%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9%, 7%, 7.1%, 7.2%, 7.3%, 7.4%, 7.5%, 7.6%, 7.7%, 7.8%, 7.9%, 8%,

[0284] 8.1%, 8.2%, 8.3%, 8.4%, 8.5%, 8.6%, 8.7%, 8.8%, 8.9%, 9%, 9.1%, 9.2%, 9.3%, 9.4%, 9.5%,

[0285] 9.6%, 9.7%, 9.8%, 9.9%, or 10% (w / v). In some embodiments, sucrose is present in the pharmaceutical composition at an amount of about 1% (w / v). In some embodiments, sucrose is present at an amount of about 1.1% (w / v). In some embodiments, sucrose is present at an amount of about 1.2% (w / v). In some embodiments, sucrose is present at an amount of about 1.3% (w / v). In some embodiments, sucrose is present at an amount of about 1.4% (w / v). In some embodiments, sucrose is present at an amount of about 1.5% (w / v). In some embodiments, sucrose is present at an amount of about 1.6% (w / v). In some embodiments, sucrose is present at an amount of about 1.7% (w / v). In some embodiments, sucrose is present at an amount of about 1.8% (w / v). In some embodiments, sucrose is present at an amount of about 1.9% (w / v). In some embodiments, sucrose is present at an amount of about 2% (w / v). In some embodiments, sucrose is present at an amount of about 2. 1% (w / v). In some embodiments, sucrose is present at an amount of about 2.2% (w / v). In some embodiments, sucrose is present at an amount of about 2.3% (w / v). In some embodiments, sucrose is present at an amount of about 2.4% (w / v). In some embodiments, sucrose is present at an amount of about 2.5% (w / v). In some embodiments, sucrose is present at an amount of about 2.6% (w / v). In some embodiments, sucrose is present at an amount of about 2.7% (w / v). In some embodiments, sucrose is present at an amount of about 2.8% (w / v). In some embodiments, sucrose is present at an amount of about 2.9% (w / v). In some embodiments, sucrose is present at an amount of about 3% (w / v). In some embodiments, sucrose is present at an amount of about 3.1% (w / v). In some embodiments, sucrose is present at an amount of about 3.2% (w / v). In some embodiments, sucrose is present at an amount of about 3.3% (w / v). In some embodiments, sucrose is present at an amount of about 3.4% (w / v). In some embodiments, sucrose is present at an amount of about 3.5% (w / v). In some embodiments, sucrose is present at an amount of about 3.6% (w / v). In some embodiments, sucrose is present at an amount of about 3.7% (w / v). In some embodiments, sucrose is present at an amount of about 3.8% (w / v). In some embodiments, sucrose is present at an amount of about 3.9% (w / v). In some embodiments, sucrose is present at an amount of about 4% (w / v). In some embodiments, sucrose is present at an amount of about 4.1% (w / v). In some embodiments, sucrose is present at an amount of about 4.2% (w / v). In some embodiments, sucrose is present at an amount of about 4.3% (w / v). In some embodiments, sucrose is present at an amount of about 4.4% (w / v). In some embodiments, sucrose is present at an amount of about 4.5% (w / v). In some embodiments, sucrose is present at an amount of about 4.6% (w / v). In some embodiments, sucrose is present at an amount of about 4.7% (w / v). In some embodiments, sucrose is present at an amount of about 4.8% (w / v). In some embodiments, sucrose is present at an amount of about 4.9% (w / v). In some embodiments, sucrose is present at an amount of about 5% (w / v). In some embodiments, sucrose is present at an amount of about 5.1% (w / v). In some embodiments, sucrose is present at an amount of about 5.2% (w / v). In some embodiments, sucrose is present at an amount of about 5.3% (w / v). In some embodiments, sucrose is present at an amount of about 5.4% (w / v). In some embodiments, sucrose is present at an amount of about 5.5% (w / v). In some embodiments, sucrose is present at an amount of about 5.6% (w / v). In some embodiments, sucrose is present at an amount of about 5.7% (w / v). In some embodiments, sucrose is present at an amount of about 5.8% (w / v). In some embodiments, sucrose is present at an amount of about 5.9% (w / v). In some embodiments, sucrose is present at an amount of about 6% (w / v). In some embodiments, sucrose is present at an amount of about 6. 1% (w / v). In some embodiments, sucrose is present at an amount of about 6.2% (w / v). In some embodiments, sucrose is present at an amount of about 6.3% (w / v). In some embodiments, sucrose is present at an amount of about 6.4% (w / v). In some embodiments, sucrose is present at an amount of about 6.5% (w / v). In some embodiments, sucrose is present at an amount of about 6.6% (w / v). In some embodiments, sucrose is present at an amount of about 6.7% (w / v). In some embodiments, sucrose is present at an amount of about 6.8% (w / v). In some embodiments, sucrose is present at an amount of about 6.9% (w / v). In some embodiments, sucrose is present at an amount of about 7% (w / v). In some embodiments, sucrose is present at an amount of about 7.1% (w / v). In some embodiments, sucrose is present at an amount of about 7.2% (w / v). In some embodiments, sucrose is present at an amount of about 7.3% (w / v). In some embodiments, sucrose is present at an amount of about 7.4% (w / v). In some embodiments, sucrose is present at an amount of about 7.5% (w / v). In some embodiments, sucrose is present at an amount of about 7.6% (w / v). In some embodiments, sucrose is present at an amount of about 7.7% (w / v). In some embodiments, sucrose is present at an amount of about 7.8% (w / v). In some embodiments, sucrose is present at an amount of about 7.9% (w / v). In some embodiments, sucrose is present at an amount of about 8% (w / v). In some embodiments, sucrose is present at an amount of about 8.1% (w / v). In some embodiments, sucrose is present at an amount of about 8.2% (w / v). In some embodiments, sucrose is present at an amount of about 8.3% (w / v). In some embodiments, sucrose is present at an amount of about 8.4% (w / v). In some embodiments, sucrose is present at an amount of about 8.5% (w / v). In some embodiments, sucrose is present at an amount of about 8.6% (w / v). In some embodiments, sucrose is present at an amount of about 8.7% (w / v). In some embodiments, sucrose is present at an amount of about 8.8% (w / v). In some embodiments, sucrose is present at an amount of about 8.9% (w / v). In some embodiments, sucrose is present at an amount of about 9% (w / v). In some embodiments, sucrose is present at an amount of about 9.1% (w / v). In some embodiments, sucrose is present at an amount of about 9.2% (w / v). In some embodiments, sucrose is present at an amount of about 9.3% (w / v). In some embodiments, sucrose is present at an amount of about 9.4% (w / v). In some embodiments, sucrose is present at an amount of about 9.5% (w / v). In some embodiments, sucrose is present at an amount of about 9.6% (w / v). In some embodiments, sucrose is present at an amount of about 9.7% (w / v). In some embodiments, sucrose is present at an amount of about 9.8% (w / v). In some embodiments, sucrose is present at an amount of about 9.9% (w / v). In some embodiments, sucrose is present at an amount of about 10% (w / v). In some embodiments, the pharmaceutical compositions comprise an antioxidant. In some embodiments, the antioxidant is an amino acid. In some embodiments, the antioxidant comprises methionine, L-methionine, arginine, glycine, histidine, or proline. In some embodiments, the antioxidant is methionine, L-methionine, arginine, glycine, histidine, or proline. In some embodiments, the antioxidant is methionine. In some embodiments, the antioxidant is L-methionine. In some embodiments, the antioxidant is arginine. In some embodiments, the antioxidant is glycine. In some embodiments, the antioxidant is histidine. In some embodiments, the antioxidant is proline.

[0286] In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise methionine. Methionine is an essential amino acid that can be represented by the chemical formula:

[0287] Methionine, as used herein, includes the free base form of methionine, as well as any and all salts thereof. In some embodiments, methionine includes a pharmaceutically acceptable salt thereof, e.g., methionine hydrochloride, methionine, as used herein, also includes all enantiomers (e.g., L- methionine and S-methionine), and any combination of enantiomers (e.g., 50% L-methionine and 50% S-methionine; 90%-100% L-methionine and 10%-0% S-methionine, etc.). In some embodiments, the term "methionine " includes greater than 99% L-methionine and less than 1% S- methionine. In some embodiments, the term "methionine " includes an enantomerically pure L- methionine. In some embodiments, methionine is a pharmaceutical grade methionine.

[0288] In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise arginine. Arginine is a conditionally non-essential amino acid that can be represented by the chemical formula:

[0289] Arginine, as used herein, includes the free base form of arginine, as well as any and all salts thereof. In some embodiments, arginine includes a pharmaceutically acceptable salt thereof, e.g., arginine hydrochloride. Arginine, as used herein, also includes all enantiomers (e.g., L-arginine and S- arginine), and any combination of enantiomers (e.g., 50% L-arginine and 50% S-arginine; 90%-

[0290] 100% L-arginine and 10%-0% S-arginine, etc.). In some embodiments, the term "arginine" includes greater than 99% L-arginine and less than 1% S-arginine. In some embodiments, the term "arginine" includes an enantomerically pure L- arginine. In some embodiments, arginine is a pharmaceutical grade arginine.

[0291] In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise glycine. Glycine is an amino acid that can be represented by the chemical formula:

[0292] Glycine, as used herein, includes the free base form of glycine, as well as any and all salts thereof. In some embodiments, arginine includes a pharmaceutically acceptable salt thereof, e.g., glycine hydrochloride. Glycine, as used herein, also includes all enantiomers (e.g., L-glycine and S- glycine), and any combination of enantiomers (e.g., 50% L-glycine and 50% S-glycine; 90%-100% L-glycine and 10%-0% S-glycine, etc.). In some embodiments, the term "glycine " includes greater than 99% L-glycine and less than 1% S-glycine. In some embodiments, the term "glycine " includes an enantomerically pure L-glycine. In some embodiments, glycine is a pharmaceutical grade glycine.

[0293] In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise histidine. Histidine is an essential amino acid that can be represented by the chemical formula:

[0294] Histidine, as used herein, includes the free base form of histidine, as well as any and all salts thereof. In some embodiments, histidine includes a pharmaceutically acceptable salt thereof, e.g., histidine hydrochloride. Histidine, as used herein, also includes all enantiomers (e.g., L-histidine and S-histidine), and any combination of enantiomers (e.g., 50% L-histidine and 50% S-histidine; 90%-100% L-histidine and 10%-0% S-histidine, etc.). In some embodiments, the term "histidine " includes greater than 99% L-histidine and less than 1% S-histidine. In some embodiments, the term "histidine " includes an enantomerically pure L-histidine. In some embodiments, histidine is a pharmaceutical grade histidine. In some embodiments, anti-FcRn antibody pharmaceutical compositions of the present disclosure comprise proline. Proline is an amino acid that can be represented by the chemical formula:

[0295] Proline, as used herein, includes the free base form of proline, as well as any and all salts thereof. In some embodiments, proline includes a pharmaceutically acceptable salt thereof, e.g., proline hydrochloride. Proline, as used herein, also includes all enantiomers (e.g., L-proline and S-proline), and any combination of enantiomers (e.g., 50% L-proline and 50% S-proline; 90%-100% L-proline and 10%-0% S-proline, etc.). In some embodiments, the term "proline" includes greater than 99% L-proline and less than 1% S-proline. In some embodiments, the term "proline" includes an enantomerically pure L-proline. In some embodiments, proline is a pharmaceutical grade proline.

[0296] Various concentrations of an antioxidant can be present in the anti-FcRn antibody pharmaceutical compositions of the present disclosure. In some embodiments, the pharmaceutical composition comprises greater than 0. 1 mg / mL of the antioxidant, greater than 0.5 mg / mL of the antioxidant, or greater than 1 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises up to 0.5 mg / mL of the antioxidant, up to 1 mg / mL of the antioxidant, up to 1.5 mg / mL of the antioxidant, or up to 2 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0.1 mg / mL to about 3 mg / mL, about 0. 1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.3 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.4 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.5 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.6 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.7 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.8 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 0.9 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1. 1 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.2 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.3 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.4 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.5 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.6 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.8 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 1.9 mg / mL of the antioxidant. In some embodiments, the pharmaceutical composition comprises about 2 mg / mL of the antioxidant.

[0297] In some embodiments, the antioxidant is methionine. In some embodiments, the pharmaceutical composition comprises greater than 0.1 mg / mL of methionine, greater than 0.5 mg / mL of methionine, or greater than 1 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises up to 0.5 mg / mL of methionine, up to 1 mg / mL of methionine, up to 1.5 mg / mL of methionine, or up to 2 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0. 1 mg / mL to about 6 mg / mL, about 0. 1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0.1 mg / mL to about 3 mg / mL, about 0.1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.3 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.4 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.5 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.6 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.7 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.8 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 0.9 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.1 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.2 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.3 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.4 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.5 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.6 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.8 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 1.9 mg / mL of methionine. In some embodiments, the pharmaceutical composition comprises about 2 mg / mL of methionine.

[0298] In some embodiment, the antioxidant is L-methionine. In some embodiments, the pharmaceutical composition comprises greater than 0.1 mg / mL of L-methionine, greater than 0.5 mg / mL of L-methionine, or greater than 1 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises up to 0.5 mg / mL of L-methionine, up to 1 mg / mL of L- methionine, up to 1.5 mg / mL of L-methionine, or up to 2 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0. 1 mg / mL to about 6 mg / mL, about 0. 1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0.1 mg / mL to about 3 mg / mL, about 0.1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.3 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.4 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.5 mg / mL of L- methionine. In some embodiments, the pharmaceutical composition comprises about 0.6 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.7 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.8 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 0.9 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.1 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.2 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.3 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.4 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.5 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.6 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 1.8 mg / mL of L- methionine. In some embodiments, the pharmaceutical composition comprises about 1.9 mg / mL of L-methionine. In some embodiments, the pharmaceutical composition comprises about 2 mg / mL of L-methionine.

[0299] In some embodiments, the antioxidant is arginine. In some embodiments, the pharmaceutical composition comprises greater than 0.1 mg / mL of arginine, greater than 0.5 mg / mL of arginine, or greater than 1 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises up to 0.5 mg / mL of arginine, up to 1 mg / mL of arginine, up to 1.5 mg / mL of arginine, or up to 2 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0. 1 mg / mL to about 10 mg / mL, about 0. 1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0. 1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.3 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.4 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.5 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.6 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.7 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.8 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 0.9 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.1 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.2 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.3 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.4 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.5 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.6 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.8 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 1.9 mg / mL of arginine. In some embodiments, the pharmaceutical composition comprises about 2 mg / mL of arginine.

[0300] In some embodiments, the antioxidant is glycine. In some embodiments, the pharmaceutical composition comprises greater than 0.1 mg / mL of glycine, greater than 0.5 mg / mL of glycine, or greater than 1 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises up to 0.5 mg / mL of glycine, up to 1 mg / mL of glycine, up to 1.5 mg / mL of glycine, or up to 2 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0. 1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0. 1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0. 1 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.3 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.4 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.5 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.6 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.7 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.8 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 0.9 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.1 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.2 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.3 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.4 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.5 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.6 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.8 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 1.9 mg / mL of glycine. In some embodiments, the pharmaceutical composition comprises about 2 mg / mL of glycine.

[0301] In some embodiments, the antioxidant is proline. In some embodiments, the pharmaceutical composition comprises greater than 0.1 mg / mL of proline, greater than 0.5 mg / mL of proline, or greater than 1 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises up to 0.5 mg / mL of proline, up to 1 mg / mL of proline, up to 1.5 mg / mL of proline, or up to 2 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0. 1 mg / mL to about 5 mg / mL, about 0.1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0. 1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.1 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.2 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.3 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.4 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.5 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.6 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.7 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.8 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 0.9 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.1 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.2 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.3 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.4 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.5 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.6 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.7 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.8 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 1.9 mg / mL of proline. In some embodiments, the pharmaceutical composition comprises about 2 mg / mL of proline.

[0302] The term “viscosity-lowering agent,” as used herein, refers to a compound which acts to reduce the viscosity of a solution relative to the viscosity of the solution absent the viscositylowering agent. The viscosity-lowering agent may be a single compound or may be a mixture of one or more compounds. When the viscosity-lowering agent is a mixture of two or more compounds, the listed concentration refers to each individual agent, unless otherwise specified.

[0303] In some embodiments, the viscosity-lowering agent is an organic base. Non-limiting examples of organic bases include N-methylglucamine, morpholine, piperidine, and primary, secondary, tertiary, and quaternary amines, substituted amines, and cyclic amines, such as, but not limited to isopropylamine, trimethylamine, diethylamine, triethylamine, tripropylamine, ethanolamine, 2-diethylaminoethanol, trimethamine, dicyclohexylamine, lysine, arginine, histidine, caffeine, procaine, lidocaine, hydrabamine, cholines, betaines, choline, betaine, ethylenediamine, theobromine, purines, piperazine, N-ethylpiperidine, N-methylpiperidinepolyamine. In some embodiments, the organic base is arginine, histidine, lysine, ethanolamine, thiamine, 2-amino-2- hydroxymethyl-propane-l,3-diol (TRIS), 4-aminopyridine, aminocyclohexane carboxylic acid, l-o- tolybiguanide, omidazole, urea, nictoinamide, benzethonium chloride, 5 -amino- 1 -pentanol, 2-(2- aminoethoxy)ethanol, trans-cyclohexane- 1,4-diamine, trans-cyclohexane- 1 R, 2R-diamine, ethylenediamine, propane-1, 3-diamine, butane- 1,4-diamine, pentane- 1,5 -diamine, hexane-1,6- diamine, octane- 1,8-diamine, 5-amino-I -pentanol, 2-(2-aminoethoxy)ethanamine, 2-(2-(2- aminoethoxy)-ethoxy)ethanamine, 3-(4-(3-aminopropoxy)-butoxy)propan-l-amine, 3424243- aminopropoxy)-ethoxy)-ethoxy)propan- 1 -amine, N-(2-(2-aminoethylamino)ethyl)ethane- 1 ,2- diamine, N-(2-aminoethyl)ethane- 1 ,2-diamine, N- 1 -(2-(2-(2-aminoethylamino)ethylamino)- ethyl)ethane- 1 ,2-diamine, N,N-dimethylhexane- 1 ,6-diamine, N,N,N,N-tetramethylbutane- 1 ,4- diamine, phenyltrimethylammonium salts, isopropylamine, diethylamine, ethanolamine, trimethamine, choline, l-(3-aminopropyl)-2 -methyl- IH-imidazole, piperazine, l-(2- aminoethyl)piperazine, l-[3-(dimethylamino)propyl]piperazine, I-(2-aminoethyl)piperidine, 2-(2- aminoethyl-l-methylpyrrolidine, mixtures thereof, and pharmaceutically acceptable salts thereof. In preferred embodiments, the organic base is arginine, or a pharmaceutically acceptable salt thereof. In preferred embodiments, the viscosity-lowering agent is arginine, or a pharmaceutically acceptable salt thereof. In preferred embodiments, the viscosity-lowering agent is arginine hydrochloride.

[0304] In some embodiments, viscosity analysis is conducted with a Pressure-Driven Slit viscometer with a flow channel depth of 51.1 pm. For example, a ImL syringe was used for all measurements. The instrument was washed with appropriate detergent prior to any sample analysis. The flow rate was 40 pL / minute, the pause time was 3 seconds, and the Minimum Slope Fit R- squared was 0.98. All measurements conducted at ambient room temperature (~25°C). The instrument was flushed with water between each sample tested.

[0305] In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 1 mM to about 500 mM. In some embodiments, the viscositylowering agent is present in the pharmaceutical composition at an amount of about 1 mM to about 500 mM, about 25 mM to about 450 mM, about 50 mM to about 400 mM, about 50 mM to about 350 mM, about 50 mM to about 300 mM, about 50 mM to about 250 mM, or about 50 mM to about 200 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 1 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 25 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 50 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 60 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 70 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 80 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 90 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 100 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 110 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 120 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 130 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 140 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 150 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 160 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 170 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 180 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 190 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 200 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 200 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 225 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 250 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 275 mM. In some embodiments, the viscositylowering agent is present in the pharmaceutical composition at a concentration up to 300 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 325 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 350 mM. In some embodiments, the viscositylowering agent is present in the pharmaceutical composition at a concentration up to 375 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 400 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 425 mM. In some embodiments, the viscositylowering agent is present in the pharmaceutical composition at a concentration up to 450 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 475 mM. In some embodiments, the viscosity-lowering agent is present in the pharmaceutical composition at a concentration up to 500 mM. In some embodiments, the viscositylowering agent is present in the pharmaceutical composition at amount of about 65 mM, about 121 mM, or about 150 mM.

[0306] In some embodiments, the viscosity-lowering agent is arginine, or a pharmaceutically acceptable salt thereof. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 1 mM to about 500 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 1 mM to about 500 mM, about 25 mM to about 450 mM, about 50 mM to about 400 mM, about 50 mM to about 350 mM, about 50 mM to about 300 mM, about 50 mM to about 250 mM, or about 50 mM to about 200 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 1 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 25 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 50 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 60 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 70 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 80 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 90 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 100 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 110 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 120 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 130 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 140 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 150 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 160 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 170 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 180 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 190 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 200 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 200 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 225 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 250 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 275 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 300 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 325 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 350 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 375 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 400 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 425 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 450 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 475 mM. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 500 mM. In some embodiments, the arginine, or a pharmaceutically acceptable salt thereof, is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM.

[0307] In some embodiments, the viscosity-lowering agent is arginine hydrochloride. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 1 mM to about 500 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 1 mM to about 500 mM, about 25 mM to about 450 mM, about 50 mM to about 400 mM, about 50 mM to about 350 mM, about 50 mM to about 300 mM, about 50 mM to about 250 mM, or about 50 mM to about 200 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 1 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 25 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 50 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 60 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 70 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 80 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 90 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 100 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 110 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 120 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 130 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 140 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 150 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 160 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 170 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 180 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 190 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 200 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 200 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 225 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 250 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 275 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 300 mM. In some embodiments, arginine hydrochloride is used as the viscositylowering agent and is present in the pharmaceutical composition at a concentration up to 325 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 350 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 375 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 400 mM. In some embodiments, arginine hydrochloride is used as the viscosity- lowering agent and is present in the pharmaceutical composition at a concentration up to 425 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 450 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 475 mM. In some embodiments, arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at a concentration up to 500 mM. In some embodiments, the arginine hydrochloride is used as the viscosity-lowering agent and is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM.

[0308] One of the major stresses proteins (e.g., antibodies) may encounter is interfacial stress (e.g., from air / water interfaces in liquid compositions, or ice / water interfaces during freezing / thawing.) Surfactants are typically used to stabilize proteins in biopharmaceutical compositions while under stress or long-term storage to prevent or minimize aggregation and / or particle formation. Examples of a surfactant include, but are not limited to, anionic surfactants (e.g., ammonium lauryl sulfate, sodium lauryl sulfate, sodium laureth sulfate, sodium myreth sulfate, diocytl sodium sulfosuccinate, perfluorooctanesulfonate, perfluorobutanesulfonate, alkyl-aryl ether phosphates, alkyl ether phosphates, carboxylates, sodium lauroyl sarcosinate, perfluorononanoate, perfluorooctanoate); cationic surfactants (e.g., octenidine dihydrochloride, cetrimonium bromide, cetylpyridinium chloride, benzalkonium chloride, benzethonium chloride, dimethyldioctadecylammonium chloride, and dioctadecyldimethylammonium bromide); zwitterionic (amphoteric) surfactants (e.g., 3- [(3- cholamidopropyl)dimethylammonio]-l -propanesulfonate, cocamidopropyl hydroxysultaine, phosphatidylserine, phosphatidylethanolamine, phosphatidylcholine, sphingomyelins, lauryldimethylamine oxide and myristamine oxide); non-ionic surfactants (e.g., polysorbates or Brij series); ethoxylates (e.g., fatty alcohol ethoxylate (e.g., octaethylene glycol monododecyl ether and pentaethylene glycol monododecyl ether), alkylphenolethoxylates (e.g., nonoxynols and Triton X- 100); fatty acid ethoxylates, ethoxylated amines and / or fatty acid amides (e.g., poly ethoxylated tallow amine, cocamide monoethanol amine, and cocamide diethanolamine); terminally blocked ethoxylates (e.g., pol oxamers); fatty acid esters of polyhydroxy compounds; fatty acid esters of glycerol (e.g., glycerol monostearate and glycerol monolaurate); fatty acid esters of sorbitol (e.g., Spans such as sorbitan monolaurate, sorbitan monostearate, and sorbitan tristearate, and Tweens such as Tween 20, Tween 40, Tween 60, and Tween 80); fatty acid esters of sucrose; alkyl poly glucosides (e.g., decyl glucoside, lauryl glucoside, and octyl glucoside); of a combination thereof.

[0309] In some embodiments, the surfactant is polysorbate 80 (PS80). PS80 is also known as polyoxyethylene (20) sorbitan monooleate, and is represented by the chemical formula:

[0310] In some embodiments, PS80 is present in the pharmaceutical composition at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about

[0311] 0.09% (w / v). In some embodiments, PS 80 is present at an amount of about 0.005% (w / v). In some embodiments, PS80 is present at an amount of about 0.01% (w / v). In some embodiments, PS80 is present at an amount of about 0.02% (w / v). In some embodiments, PS80 is present at an amount of about 0.03% (w / v). In some embodiments, PS80 is present at an amount of about 0.04% (w / v). In some embodiments, PS80 is present at an amount of about 0.05% (w / v). In some embodiments,

[0312] PS80 is present at an amount of about 0.06% (w / v). In some embodiments, PS80 is present at an amount of about 0.07% (w / v). In some embodiments, PS80 is present at an amount of about 0.08% (w / v). In some embodiments, PS80 is present at an amount of about 0.09% (w / v). In some embodiments, PS80 is present at an amount of about 0.1% (w / v). In some embodiments, PS80 is present at an amount of about 0.2% (w / v). In some embodiments, PS80 is present at an amount of about 0.3% (w / v). In some embodiments, PS80 is present at an amount of about 0.4% (w / v). In some embodiments, PS80 is present at an amount of about 0.5% (w / v). In some embodiments, PS80 is present at an amount of about 0.6% (w / v). In some embodiments, PS80 is present at an amount of about 0.7% (w / v). In some embodiments, PS80 is present at an amount of about 0.8% (w / v). In some embodiments, PS80 is present at an amount of about 0.9% (w / v). In some embodiments, PS80 is present at an amount of about 1% (w / v).

[0313] In some embodiments, the surfactant is polysorbate 20 (PS20). PS20 is also known as polyoxyethylene (20) sorbitan monolaurate, and is represented by the chemical formula: In some embodiments, PS20 is present in the pharmaceutical composition at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v). In some embodiments, PS20 is present at an amount of about 0.005% (w / v). In some embodiments, PS20 is present at an amount of about 0.01% (w / v). In some embodiments, PS20 is present at an amount of about 0.02% (w / v). In some embodiments, PS20 is present at an amount of about 0.03% (w / v). In some embodiments, PS20 is present at an amount of about 0.04% (w / v). In some embodiments, PS20 is present at an amount of about 0.05% (w / v). In some embodiments, PS20 is present at an amount of about 0.06% (w / v). In some embodiments, PS20 is present at an amount of about 0.07% (w / v). In some embodiments, PS20 is present at an amount of about 0.08% (w / v). In some embodiments, PS20 is present at an amount of about 0.09% (w / v). In some embodiments, PS20 is present at an amount of about 0.1% (w / v). In some embodiments, PS20 is present at an amount of about 0.2% (w / v). In some embodiments, PS20 is present at an amount of about 0.3% (w / v). In some embodiments, PS20 is present at an amount of about 0.4% (w / v). In some embodiments, PS20 is present at an amount of about 0.5% (w / v). In some embodiments, PS20 is present at an amount of about 0.6% (w / v). In some embodiments, PS20 is present at an amount of about 0.7% (w / v). In some embodiments, PS20 is present at an amount of about 0.8% (w / v). In some embodiments, PS20 is present at an amount of about 0.9% (w / v). In some embodiments, PS20 is present at an amount of about 1% (w / v).

[0314] In some embodiments, the surfactant is a poloxamer. Poloxamers are nonionic triblock copolymers composed of a central hydrophobic chain of polyoxypropylene (polypropylene oxide)) flanked by two hydrophilic chains of polyoxyethylene (polyethylene oxide)). Examples of a poloxamer include, but are not limited to, poloxamer 188, poloxamer 407, poloxamer 184, poloxamer 124, or a combination thereof. In some embodiments, the surfactant is poloxamer 188. In some embodiments, the surfactant is poloxamer 407. In some embodiments, the surfactant is poloxamer 184. In some embodiments, the surfactant is poloxamer 124. In some embodiments, the poloxamer is present at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.005% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.01% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.02% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.03% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.04% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.05% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.06% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.07% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.08% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.09% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.1% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.2% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.3% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.4% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.5% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.6% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.7% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.8% (w / v). In some embodiments, the poloxamer is present at an amount of about 0.9% (w / v). In some embodiments, the poloxamer is present at an amount of about 1% (w / v).

[0315] In some embodiments, the pH of the pharmaceutical composition is about 5.0 to about 6.5. In some embodiments, the pH of the pharmaceutical composition is about 5.5 to about 6.5. In some embodiments, the pH of the pharmaceutical composition is about 5.0. In some embodiments, the pH of the pharmaceutical composition is about 5.5. In some embodiments, the pH of the pharmaceutical composition is about 6.0. In some embodiments, the pH of the pharmaceutical composition is about

[0316] 6.5. In some embodiments, the pH of the pharmaceutical composition is 5.0, 5.1, 5.2, 5.3, 5.4, 5.5,

[0317] 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, or 6.5. In some embodiments, the pH of the pharmaceutical composition is 5.0. In some embodiments, the pH of the pharmaceutical composition is 5.1. In some embodiments, the pH of the pharmaceutical composition is 5.2. In some embodiments, the pH of the pharmaceutical composition is 5.3. In some embodiments, the pH of the pharmaceutical composition is 5.4. In some embodiments, the pH of the pharmaceutical composition is 5.5. In some embodiments, the pH of the pharmaceutical composition is 5.6. In some embodiments, the pH of the pharmaceutical composition is 5.7. In some embodiments, the pH of the pharmaceutical composition is 5.8. In some embodiments, the pH of the pharmaceutical composition is 5.9. In some embodiments, the pH of the pharmaceutical composition is 6.0. In some embodiments, the pH of the pharmaceutical composition is 6.1. In some embodiments, the pH of the pharmaceutical composition is 6.2. In some embodiments, the pH of the pharmaceutical composition is 6.3. In some embodiments, the pH of the pharmaceutical composition is 6.4. In some embodiments, the pH of the pharmaceutical composition is 6.5.

[0318] In some embodiments, a pharmaceutical composition comprises: (i) an anti-FcRn antibody, or antigen-binding fragment thereof, as described herein, at an amount of about 50 mg / mL to about 500 mg / mL; (ii) a buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) an antioxidant, at an amount of about 0.1 mg / mL to about 10 mg / mL; (v) a viscosity-lowering agent at an amount of about 1 mM to about 500 mM; and (vi) a surfactant at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5. In some embodiments, a pharmaceutical composition comprises: (i) an anti-FcRn antibody, or antigen-binding fragment thereof, as described herein, at an amount of about 1 mg / mL to about 500 mg / mL; (ii) a histidine buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) methionine, at an amount of about 0.1 mg / mL to about 10 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about ImM to about 500 mM; and (vi) a polysorbate at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

[0319] In some embodiments, a pharmaceutical composition comprises:

[0320] (i) nipocalimab at an amount of 230 mg / mL;

[0321] (ii) Histidine at an amount of 10 mM;

[0322] (iii) Arginine HC1 at an amount of 150 mM;

[0323] (iv) sucrose at an amount of 8%;

[0324] (v) methionine at an amount of 1 mg / mL; and

[0325] (vi) PS80 at an amount of 0.06% (w / v),

[0326] (vii) wherein the pH of the pharmaceutical composition is 6.

[0327] In some embodiments, a pharmaceutical composition comprises:

[0328] (i) nipocalimab at an amount of 100 mg / mL;

[0329] (ii) Histidine at an amount of 10 mM;

[0330] (iii) Arginine HC1 at an amount of 65 mM;

[0331] (iv) sucrose at an amount of 3.5%;

[0332] (v) methionine at an amount of 1 mg / mL; and

[0333] (vi) PS80 at an amount of 0.06% (w / v),

[0334] (vii) wherein the pH of the pharmaceutical composition is 6.

[0335] In some embodiments, a pharmaceutical composition comprises:

[0336] (i) nipocalimab at an amount of 185 mg / mL;

[0337] (ii) Histidine at an amount of 10 mM;

[0338] (iii) Arginine HC1 at an amount of 121 mM;

[0339] (iv) sucrose at an amount of 6.4%; (v) methionine at an amount of 1 mg / mL; and

[0340] (vi) PS80 at an amount of 0.06% (w / v),

[0341] (vii) wherein the pH of the pharmaceutical composition is 6.

[0342] In some embodiments, the anti-FcRn antibody is such as those provided herein. In some embodiments, the pharmaceutical composition comprises the anti-FcRn antibody, or antibody fragment thereof, comprising nipocalimab.

[0343] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising (i) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence comprises the amino acid sequence SEQ ID NO: 3; the light chain CDR2 sequence comprises the amino acid sequence of SEQ ID NO: 4; and the light chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence comprises the amino acid sequence of SEQ ID NO: 6; the heavy chain CDR2 comprises the amino acid sequence of SEQ ID NO: 7; and the heavy chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 8; or variants of any of the foregoing; or variants of any of the foregoing.

[0344] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising (i) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence comprises the amino acid sequence SEQ ID NO: 3; the light chain CDR2 sequence comprises the amino acid sequence of SEQ ID NO: 4; and the light chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence comprises the amino acid sequence of SEQ ID NO: 11; the heavy chain CDR2 comprises the amino acid sequence of SEQ ID NO: 12; and the heavy chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 8; or variants of any of the foregoing; or variants of any of the foregoing.

[0345] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising (i) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence comprises the amino acid sequence SEQ ID NO: 3; the light chain CDR2 sequence comprises the amino acid sequence of SEQ ID NO: 4; and the light chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence comprises the amino acid sequence of SEQ ID NO: 6; the heavy chain CDR2 comprises the amino acid sequence of SEQ ID NO: 12; and the heavy chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 8.

[0346] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising (i) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence comprises the amino acid sequence SEQ ID NO: 3; the light chain CDR2 sequence comprises the amino acid sequence of SEQ ID NO: 4; and the light chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence comprises the amino acid sequence of SEQ ID NO: 6; the heavy chain CDR2 comprises the amino acid sequence of SEQ ID NO: 17; and the heavy chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 8; or variants of any of the foregoing; or variants of any of the foregoing.

[0347] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising (i) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence comprises the amino acid sequence SEQ ID NO: 3; the light chain CDR2 sequence comprises the amino acid sequence of SEQ ID NO: 4; and the light chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence comprises the amino acid sequence of SEQ ID NO: 18; the heavy chain CDR2 comprises the amino acid sequence of SEQ ID NO: 7; and the heavy chain CDR3 sequence comprises the amino acid sequence of SEQ ID NO: 8; or variants of any of the foregoing; or variants of any of the foregoing.

[0348] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16. In some embodiments, the pharmaceutical composition comprises an anti- FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 13. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 14. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 15. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 16.

[0349] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a heavy chain polypeptide having a sequence of SEQ ID NO: 2, 13, 14, 15, or 16. In some embodiments, the pharmaceutical composition comprises an anti- FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence of SEQ ID NO: 2, 13, 14, 15, or 16. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence of SEQ ID NO: 2. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence of SEQ ID NO: 13. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence of SEQ ID NO: 14. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence of SEQ ID NO: 15. In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody, or antibody fragment thereof, comprising a light chain polypeptide having a sequence of SEQ ID NO: 1; and a heavy chain polypeptide having a sequence of SEQ ID NO: 16.

[0350] In some embodiments, a pharmaceutical composition comprises: (i) an anti-FcRn antibody, or antigen-binding fragment thereof, as described herein, at an amount of about 1 mg / mL to about 500 mg / mL; ii) a histidine buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and (vi) a polysorbate 80 at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical compositions is about 5.5 to about 6.5.

[0351] In some embodiments, a pharmaceutical composition comprises: (i) an anti-FcRn antibody, or antigen-binding fragment thereof, comprising: a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1 and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16; (ii) a buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) an antioxidant, at an amount of about 0.1 mg / mL to about 10 mg / mL; (v) a viscosity-lowering agent at an amount of about 1 mM to about 500 mM; and (vi) a surfactant at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

[0352] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 1 mg / mL to about 500 mg / mL; (ii) a buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) an antioxidant, at an amount of about 0.1 mg / mL to about 10 mg / mL; (v) a viscosity-lowering agent at an amount of about 1 mM to about 500 mM; and (vi) a surfactant at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5. In some embodiments, a pharmaceutical composition comprises: (i) an anti-FcRn antibody, or antigen-binding fragment thereof, comprising: a light chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1 and a heavy chain polypeptide having a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16 at an amount of about 1 mg / mL to about 500 mg / mL; (ii) a histidine buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and (vi) a polysorbate 80 at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical compositions is about 5.5 to about 6.5.

[0353] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 1 mg / mL to about 500 mg / mL; (ii) a histidine buffer at an amount of about 1 mM to about 50 mM; (iii) sucrose at an amount of about 1% to about 20% (w / v); (iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and (vi) a polysorbate 80 at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

[0354] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 185 mg / mL to about 230 mg / mL; (ii) a histidine buffer at an amount of about 5 mM to about 15 mM; (iii) sucrose at an amount of about 5% to about 10% (w / v); (iv) methionine, at an amount of about 0.5 mg / mL to about 1.5 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 100 mM to about 200 mM; and (vi) a polysorbate 80 at an amount of about 0.03% to about 0.09% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

[0355] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 185 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 6.4% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 120 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6.0.

[0356] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 200 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 7% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 130 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6.0.

[0357] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 230 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 8% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 150 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6.0.

[0358] In some embodiments, the pharmaceutical composition has a viscosity from about 10 cP to about 40 cP. In some embodiments, the pharmaceutical composition has viscosity of about 10 cP, about 11 cP, about 12 cP, about 13 cP, about 14 cP, about 15 cP, about 16 cP, about 17 cP, about 16 cP, about 17 cP, about 18 cP, about 19 cP, about 20 cP, about 21 cP, about 22 cP, about 23 cP, about 24 cP, about 25 cP, about 26 cP, about 27 cP, about 28 cP, about 29 cP, about 30 cP, about 31 cP, about 32 cP, about 33 cP, about 34 cP, about 35 cP, about 36, cP, about 37, cP, about 38 cP, about 39 cP, or about 40 cP.

[0359] In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is equal or less than 40 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is less than 40 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is equal or less than 30 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is less than 30 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is equal or less than 25 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is less than 25 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is equal or less than 20 cP. In some embodiments, the pharmaceutical composition has viscosity at 25 °C that is less than 20 cP.

[0360] In some embodiments, the pharmaceutical composition has a viscosity at 25 °C less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP, after storage for about 24 months or more and at a temperature of about 5 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25°C less than about 40 cP after storage for about 24 months or more and at a temperature of about 5 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25 °C less than about 30 cP after storage for about 24 months or more and at a temperature of about 5 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25°C less than about 25 cP after storage for about 24 months or more and at a temperature of about 5 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25 °C less than about 20 cP, after storage for about 24 months or more and at a temperature of about 5°C. In some embodiments, the pharmaceutical composition has a viscosity at 25 °C less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP, after storage for about 12 months or more and at a temperature of about 25 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25°C less than about 40 cP after storage for about 12 months or more and at a temperature of about 25 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25 °C less than about 30 cP after storage for about 12 months or more and at a temperature of about 25°C. In some embodiments, the pharmaceutical composition has a viscosity at 25°C less than about 25 cP after storage for about 12 months or more and at a temperature of about 25 °C. In some embodiments, the pharmaceutical composition has a viscosity at 25°C less than about 20 cP, after storage for about 12 months or more and at a temperature of about 25 °C.

[0361] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 100 mg / mL to about 250 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 3% to about 8% (w / v); (iv) methionine, at an amount of about 1 mg / mL; (v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 50 mM to about 200 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6.

[0362] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 185 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 6.4% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 120 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6.0.

[0363] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 100 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 3.5% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 65 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6.0.

[0364] In some embodiments, a pharmaceutical composition comprises: (i) nipocalimab at an amount of about 230 mg / mL; (ii) a histidine buffer at an amount of about 10 mM; (iii) sucrose at an amount of about 8% (w / v); (iv) methionine at an amount of about 1 mg / mL; (v) arginine hydrochloride at an amount of about 150 mM; and (vi) a polysorbate 80 at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6.0.

[0365] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody comprising a light chain comprising the sequence of SEQ ID NO: 1 and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some or all of the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (i.e., it’s heavy chain). In some embodiments, the anti-FcRn antibody further comprises the additional lysine residue at the C- terminus of SEQ ID NO: 2 only in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1- 5%, or about 1-4%, or about 1-3%, or about 1-2% of the total amount of anti-FcRn antibody in the pharmaceutical composition. For example, in some embodiments, about 90-99.9%, or about 92- 99.5%, or about 95-99.5%, or about 95-99%, or about 96-99%, or about 97-99%, or about 98-99% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2, while about 0. 1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1- 4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C- terminus. In some embodiments, the anti-FcRn antibody further comprises the additional lysine residue at the C-terminus of its heavy chain only in about 1-2% of the total amount of anti-FcRn antibody in the pharmaceutical composition. For example, in some embodiments, about 98-99% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2, while about 1-2% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C- terminus.

[0366] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody comprising a light chain comprising the sequence of SEQ ID NO: 1 and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some or all of the heavy chains of the anti- FcRn antibody further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 21). In some embodiments, the heavy chains of the anti-FcRn antibodies further comprise the additional lysine residue at the C-terminus of SEQ ID NO: 2 only in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the total amount of anti-FcRn antibody heavy chains in the pharmaceutical composition. For example, in some embodiments, about 90-99.9%, or about 92-99.5%, or about 95-99.5%, or about 95-99%, or about 96-99%, or about 97-99%, or about 98-99% of the amount of the heavy chains of the anti- FcRn antibodies in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2, while about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1- 3%, or about 1-2% of the amount of anti-FcRn antibody in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C-terminus (as in SEQ ID NO: 21). In some embodiments, the anti-FcRn antibody heavy chains further comprise the additional lysine residue at the C-terminus in about 1-2% of the total amount of anti-FcRn heavy chains in the pharmaceutical composition. For example, in some embodiments, about 98-99% of the amount of the heavy chains of the anti-FcRn antibodies in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2, while about 1-2% of the amount of heavy chains of the anti- FcRn antibodies in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C-terminus.

[0367] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody comprising a light chain comprising the sequence of SEQ ID NO: 1 and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some or all of the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C- terminal proline may be amidated. In some embodiments, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated only in about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5- 1.0% of the total amount of anti-FcRn antibody in the pharmaceutical composition. For example, in some embodiments, about 99-99.1%, or about 99-99.2%, or about 95-99.3%, or about 99-99.5 of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2, while about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 that lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated only in about 0.5-1.0% of the total amount of anti- FcRn antibody in the pharmaceutical composition. For example, in some embodiments, about 99- 99.5% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2, while about 0.5-1.0% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 that lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0368] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody comprising a light chain comprising the sequence of SEQ ID NO: 1 and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some or all of the anti-FcRn antibody heavy chains lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, the heavy chains of the anti- FcRn antibodies lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated only in about 0. 1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the total amount of anti-FcRn antibody heavy chains in the pharmaceutical composition. For example, in some embodiments, about 99-99.1%, or about 99- 99.2%, or about 95-99.3%, or about 99-99.5 of the amount of heavy chains of anti-FcRn antibodies in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2, while about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the amount of heavy chains of anti- FcRn antibodies in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 that lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, the anti-FcRn antibody heavy chains lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated only in about 0.5-1.0% of the total amount of anti- FcRn antibody heavy chains in the pharmaceutical composition. For example, in some embodiments, about 99-99.5% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2, while about 0.5-1.0% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 that lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0369] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody comprising a light chain comprising the sequence of SEQ ID NO: 1 and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some of the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2 (i.e., it’s heavy chain) and some of the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, the anti-FcRn antibody further comprises the additional lysine residue at the C- terminus of SEQ ID NO: 2 only in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1- 5%, or about 1-4%, or about 1-3%, or about 1-2% of the total amount of anti-FcRn antibody in the pharmaceutical composition and the anti-FcRn antibody lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated only in about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the total amount of anti-FcRn antibody in the pharmaceutical composition. For example, in some embodiments, about 90-99.9%, or about 92-99.5%, or about 95-99.5%, or about 95-99%, or about 96-99%, or about 97- 99%, or about 98-99% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2, while about 0. 1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C-terminus and about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5- 1.0% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain that lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0370] In some embodiments, the anti-FcRn antibody further comprises the additional lysine residue at the C-terminus of its heavy chain only in about 1-2% of the total amount of anti-FcRn antibody in the pharmaceutical composition and the anti-FcRn antibody lacks the glycine reside at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline of the heavy chain may be amidated only in about 0.5-1.0% of the total amount of anti-FcRn antibody in the pharmaceutical composition. For example, in some embodiments, about 97-98.5% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2, while about 1-2% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C- terminus and about 0.5-1% of the amount of anti-FcRn antibody in the pharmaceutical composition comprises a heavy chain of SEQ ID NO: 2 that lacks the C-terminal glycine (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0371] In some embodiments, the pharmaceutical composition comprises an anti-FcRn antibody comprising a light chain comprising the sequence of SEQ ID NO: 1 and a heavy chain comprising the sequence of SEQ ID NO: 2. In some embodiments, some of the anti-FcRn antibody heavy chains further comprise an additional lysine residue at the C-terminus of SEQ ID NO: 2 and some of the anti-FcRn antibody heavy chains lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated. In some embodiments, the anti-FcRn antibody heavy chains further comprises the additional lysine residue at the C-terminus of SEQ ID NO: 2 only in about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1-5%, or about 1-4%, or about 1-3%, or about 1-2% of the total amount of anti-FcRn antibody heavy chains in the pharmaceutical composition and the anti-FcRn antibody heavy chains lack the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated only in about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the total amount of anti-FcRn antibody heavy chains in the pharmaceutical composition. For example, in some embodiments, about 90-99.9%, or about 92- 99.5%, or about 95-99.5%, or about 95-99%, or about 96-99%, or about 97-99%, or about 98-99% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2, while about 0.1-10%, or about 0.5-8%, or about 0.5-5%, or about 1- 5%, or about 1-4%, or about 1-3%, or about 1-2% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C-terminus and about 0.1-1%, or about 0.2-1.0%, or about 0.3-1.0%, or about 0.5-1.0% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain that lacks the glycine residue at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0372] In some embodiments, the anti-FcRn antibody heavy chains further comprise the additional lysine residue at the C-terminus only in about 1-2% of the total amount of anti-FcRn antibody heavy chains in the pharmaceutical composition and the anti-FcRn antibody heavy chains lack the glycine reside at the C-terminus of SEQ ID NO: 2 (as in SEQ ID NO: 20) and the resulting C- terminal proline may be amidated only in about 0.5-1.0% of the total amount of anti-FcRn antibody heavy chains in the pharmaceutical composition. For example, in some embodiments, about 97- 98.5% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2, while about 1-2% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 with an additional lysine residue at the C-terminus and about 0.5-1% of the amount of anti-FcRn antibody heavy chains in the pharmaceutical composition consist of a heavy chain of SEQ ID NO: 2 that lacks the C-terminal glycine (as in SEQ ID NO: 20) and the resulting C-terminal proline may be amidated.

[0373] In some embodiments, the pharmaceutical composition comprises at least one hyaluronidase enzyme. In some embodiments, the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

[0374] In some embodiments, the pharmaceutical composition is stable at a temperature of about 2- 8°C. In some embodiments, the pharmaceutical composition is stable after at least six months, after at least one year, or after at least two years. In some embodiments, the pharmaceutical composition is stable at a temperature of about 2-8°C after at least six months, after at least one year, or after at least two years. In some embodiments, stability is defined based on color of solution, pH, turbidity, percentage of high molecular weight species (HMWS), percentage of low molecular weight species (LMWS), percentage of sum of acidic peaks, percentage of sum of basic peaks, protein concentration, viscosity or any combination thereof. In some embodiments, stability is defined as having a pH range of 5.5 to about 6.5 after storage for about 24 months or more and at a temperature of about 5°C. In some embodiments, stability is defined as having a pH range of 5.5 to about 6.5 after storage for about 12 months or more and at a temperature of about 25 °C. In some embodiments, stability is defined as having a HMWS of about 5.0% or less after storage for about 24 months or more and at a temperature of about 5°C. In some embodiments, stability is defined as having a HMWS of about 5.0% or less after storage for about 12 months or more and at a temperature of about 25°C.

[0375] Stability: pH

[0376] Measuring the pH of the pharmaceutical composition allows confirmation that it is consistent with previous pharmaceutical composition batches at release and over the shelf life. In some embodiments, a daily calibrated electronic pH meter with standardized pH electrode is used to measure the pH of test articles. All calibration solutions, reference buffers, and test articles are equilibrated to, and maintained at, 25°C prior to and during testing.

[0377] In one embodiment, the pH ranges from about 5.5 to about 6.5 after storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the stability of the pharmaceutical composition is defined when its pH ranges from about 5.6 to about 6.4 after storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the stability of the pharmaceutical composition is defined when its pH ranges from about 5.7 to about 6.3 after storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the stability of the pharmaceutical composition is defined when its pH ranges from about 5.8 to about 6.2 after storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the stability of the pharmaceutical composition is defined when its pH ranges from about 5.9 to about 6. 1 after storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C.

[0378] Stability: Size-Exclusion HPLC (SE-HPLC)

[0379] SE-HPLC procedure allows assessing purity of the pharmaceutical composition and monitoring its stability under non-denaturing conditions at release and over the shelflife.

[0380] In some embodiments, the pharmaceutical composition stability is defined based upon various results of SE-HPLC variables such as the Main Component (MC) (also known as native form antibody), High Molecular Weight Species (HMWS), or Low Molecular Weight Species (LMWS)), after storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C.

[0381] In one embodiment, the pharmaceutical composition stability is defined as having a MC of about 95% or more. In one embodiment, the pharmaceutical composition stability is defined as having a MC of about 96% or more. In one embodiment, the pharmaceutical composition stability is defined as having a MC of about 97% or more. In one embodiment, the pharmaceutical composition stability is defined as having a MC of about 98% or more.

[0382] In one embodiment, the pharmaceutical composition stability is defined as having a HMWS of about 5% or less. In one embodiment, the pharmaceutical composition stability is defined as having a HMWS of about 4% or less. In one embodiment, the pharmaceutical composition stability is defined as having a HMWS of about to 3% or less. In one embodiment, the pharmaceutical composition stability is defined as having a HMWS of about to 2% or less.

[0383] In one embodiment, the pharmaceutical composition stability is defined as having a LMWS of about 5% or less. In one embodiment, the pharmaceutical composition stability is defined as having a LMWS of about 2% or less. In one embodiment, the pharmaceutical composition stability is defined as having a LMWS of about 1% or less. In one embodiment, the pharmaceutical composition stability is defined as having a LMWS of about 0.5% or less.

[0384] Stability: protein concentration by A280

[0385] Protein concentration of the pharmaceutical composition allows verifying that it is consistent with previous pharmaceutical composition batches at release and over the shelf life. Quantification of protein concentration can be accomplished by measuring the UV light absorbance of the drug product solution at 280 nm (A280).

[0386] In one embodiment, the pharmaceutical composition is in a 230 mg / mL Formulation and the pharmaceutical composition stability is defined as having a protein concentration of about 207 mg / mL to about 253 mg / mL after DP storage for about 12 months or more and at a temperature of about 25 °C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the pharmaceutical composition stability is defined as having a protein concentration of about 215 mg / mL to about 235 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the pharmaceutical composition stability is defined as having a protein concentration of about 220 mg / mL to about 230 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the pharmaceutical composition is in a 185 mg / mL Formulation and the pharmaceutical composition stability is defined as having a protein concentration of about 166 mg / mL to about 204 mg / mL after DP storage for about 12 months or more and at a temperature of about 25 °C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the pharmaceutical composition stability is defined as having a protein concentration of about 175 mg / mL to about 195 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the pharmaceutical composition stability is defined as having a protein concentration of about 180 mg / mL to about 190 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C.

[0387] In one embodiment, the pharmaceutical composition is in a 100 mg / mL Formulation and the pharmaceutical composition stability is defined as having a protein concentration of about 90 mg / mL to about 110 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5°C. In one embodiment, the pharmaceutical composition stability is defined as having a protein concentration of about 90 mg / mL to about 100 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5 °C. In one embodiment, the pharmaceutical composition stability is defined as having a protein concentration of about 93 mg / mL to about 98 mg / mL after DP storage for about 12 months or more and at a temperature of about 25°C, and / or after storage for about 2 years or more and at a temperature of about 5°C.

[0388] In some embodiments, the pharmaceutical composition is a stable pharmaceutical composition. In some embodiments, the stable pharmaceutical composition comprises an anti-FcRn antibody, wherein at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of the anti-FcRn antibody is present as a monomer. In some embodiments, the stable pharmaceutical composition comprises an anti-FcRn antibody,...

Claims

What is claimed is:

1. A pharmaceutical composition comprising:(i) an anti-FcRn antibody, or antigen-binding fragment thereof, at an amount of about 50 mg / mL to about 500 mg / mL;(ii) a buffer at an amount of about 1 mM to about 50 mM;(iii) polyol at an amount of about 1% to about 20% (w / v);(iv) an antioxidant, at an amount of about 0. 1 mg / mL to about 10 mg / mL;(v) a viscosity-lowering agent at an amount of about 1 mM to about 500 mM; and(vi) a surfactant at an amount of about 0.001% to about 1% (w / v), wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

2. The pharmaceutical composition of claim 1, wherein the anti-FcRn antibody, or antibody fragment thereof, comprises: a) (i) a light chain variable region comprising a light chain complementary determining region (CDR) 1 (CDR1) comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 7; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; b) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 11; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 12; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; c) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 12; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; d) (i) a light chain variable region comprising a light chain CDR1 comprisingthe sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 17; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing; or e) (i) a light chain variable region comprising a light chain CDR1 comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 18; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 7; and a heavy chain CDR3 sequence comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing.

3. The pharmaceutical composition of claim 1 or 2, wherein the anti-FcRn antibody comprises a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1.

4. The pharmaceutical composition of any one of claims 1-3, wherein the anti-FcRn antibody comprises a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%,96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16.

5. The pharmaceutical composition of any one of claims 1-4, wherein the anti-FcRn antibody comprises: a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2, 13, 14, 15, or 16.

6. The pharmaceutical composition of any one of claims 1-5, wherein the anti-FcRn antibody comprises: a) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2;b) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 13; c) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 14; d) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 15; or e) a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 16.

7. The pharmaceutical composition of any one of claims 1-6, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1.

8. The pharmaceutical composition of any one of claims 1-7, wherein the anti-FcRn antibody comprises a heavy chain comprising a sequence of SEQ ID NO: 2, 13, 14, 15, or 16.

9. The pharmaceutical composition of any one of claims 1-8, wherein the anti-FcRn antibody comprises: a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence of SEQ ID NO: 2, 13, 14, 15, or 16.

10. The pharmaceutical composition of any one of claims 1-9, wherein the anti-FcRn antibody comprises: a) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2; b) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 13;c) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 14; d) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 15; or e) a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 16.

11. The pharmaceutical composition of any one of claims 1-10, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

12. The pharmaceutical composition of any one of claims 1-11, wherein the anti-FcRn antibody is nipocalimab.

13. The pharmaceutical composition of any one of claims 1-12, wherein the anti-FcRn antibody, or antigen-binding fragment thereof, is present at an amount of about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL.

14. The pharmaceutical composition of any one of claims 1-13, wherein the anti-FcRn antibody, or antigen-binding fragment thereof, is present at an amount of about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about mg / mL, about 220 mg / mL, about 225 mg / mL, about 230 mg / mL, about 235 mg / mL, about 240 mg / mL, about 245 mg / mL, or about 250 mg / mL.

15. The pharmaceutical composition of any one of claims 1-14, wherein the anti-FcRn antibody, or antigen-binding fragment thereof, is present at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

16. The pharmaceutical composition of any one of claims 1-15, wherein the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 25 mM to about 450 mM,about 50 mM to about 400 mM, about 50 mM to about 350 mM, about 50 mM to about 300 mM, about 50 mM to about 250 mM, or about 50 mM to about 200 mM.

17. The pharmaceutical composition of any one of claims 1-16, wherein the viscosity-lowering agent is present in the pharmaceutical composition at an amount of about 50 mM, about 60 mM, about 65 mM, about 70 mM, about 80 mM, about 90 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM.

18. The pharmaceutical composition of any one of claims 1-17, wherein the viscosity-lowering agent is present in the pharmaceutical composition at an amount of 65 mM, 121 mM, or 150 mM.

19. The pharmaceutical composition of any one of claims 1-18, wherein the viscosity-lowering agent is selected from the group consisting of arginine, lysine, proline, leucine, methionine, glutamic acid, sodium chloride, mixtures thereof, and pharmaceutically acceptable salts thereof.

20. The pharmaceutical composition of any one of claims 1-19, wherein the viscosity-lowering agent is arginine, or a pharmaceutically acceptable salt thereof.

21. The pharmaceutical composition of any one of claims 1-20, wherein the viscosity-lowering agent is arginine hydrochloride.

22. The pharmaceutical composition of any one of claims 1-21, wherein the viscosity-lowering agent is arginine glutamate.

23. The pharmaceutical composition of any one of claims 1-22, wherein the buffer is histidine buffer or phosphate buffer.

24. The pharmaceutical composition of claim 23, wherein the buffer is histidine buffer.

25. The pharmaceutical composition of claim 24, wherein the histidine buffer is present at an amount of about 1 to about 50 mM.

26. The pharmaceutical composition of claim 24 or 25, wherein the histidine buffer is present atan amount of about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 11 mM, about 12 mM, about 13 mM, about 14 mM, about 15 mM, about 16 mM, about 17 mM, about 18 mM, about 19 mM, or about 20 mM.

27. The pharmaceutical composition of any one of claims 24-26, wherein the histidine buffer is present at an amount of about 10 mM.

28. The pharmaceutical composition of any one of claims 1-27, wherein the polyol is present at an amount of about 1% to about 15%, about 2% to about 10%, about 3% to about 10%, about 3% to about 9%, or about 3% to about 8% (w / v).

29. The pharmaceutical composition of any one of claims 1-28, wherein the polyol is present at an amount of about 1%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about 6.3%, about 6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v).

30. The pharmaceutical composition of any one of claims 1-29, wherein the polyol is present at an amount of about 3.5%, about 6.4%, or about 8%.

31. The pharmaceutical composition of any one of claims 1-30, wherein the polyol is a monosaccharide or a disaccharide.

32. The pharmaceutical composition of claim 31, wherein the monosaccharide is sorbitol.

33. The pharmaceutical composition of claim 31, wherein the disaccharide is sucrose ortrehalose.

34. The pharmaceutical composition of any one of claims 1-31 or 33, wherein the polyol is sucrose.

35. The pharmaceutical composition of any one of claims 1-34, wherein the antioxidant is methionine.

36. The pharmaceutical composition of any one of claims 1-35, wherein the antioxidant is L- methionine.

37. The pharmaceutical composition of claim 35 or 36, wherein the methionine is present at an amount of about 0.1 mg / mL to about 10 mg / mL, about 0.1 mg / mL to about 9 mg / mL, about 0. 1 mg / mL to about 8 mg / mL, about 0. 1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0. 1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0.1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL.

38. The pharmaceutical composition of any one of claims 35-37, wherein the methionine is present at an amount of about 0.1 mg / mL, about 0.2 mg / mL, about 0.3 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.7 mg / mL, about 0.8 mg / mL, about 0.9 mg / mL, about 1 mg / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.5 mg / mL, about 1.6 mg / mL, about 1.7 mg / mL, about 1.8 mg / mL, about 1.9 mg / mL, or about 2 mg / mL.

39. The pharmaceutical composition of any one of claims 35-38, wherein the methionine is present at an amount of about 1 mg / mL.

40. The pharmaceutical composition of any one of claims 1-39, wherein the surfactant is a polysorbate, or a poloxamer.

41. The pharmaceutical composition of claim 40, wherein the polysorbate is polysorbate 80 (PS80), or polysorbate 20 (PS20).

42. The pharmaceutical composition of claim 40 or 41, wherein the polysorbate is PS80.

43. The pharmaceutical composition of claim 42, wherein the PS80 is present at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v).

44. The pharmaceutical composition of claim 42 or 43, wherein the PS80 is present at an amount of about 0.005%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% (w / v).

45. The pharmaceutical composition of any one of claims 42-44, wherein the PS80 is present at an amount of about 0.06%.

46. The pharmaceutical composition of any one of claims 1-45, further comprising at least one hyaluronidase enzyme.

47. The pharmaceutical composition of claim 46, wherein the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

48. The pharmaceutical composition of any one of claims 1-47, wherein the pH of the pharmaceutical composition is about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6, about 6. 1, about 6.2, about 6.3, about 6.4, or about 6.5.

49. The pharmaceutical composition of any one of claims 1-48, wherein the pH of the pharmaceutical composition is about 6.

50. The pharmaceutical composition of any one of claims 1-49, comprising:(i) an anti-FcRn antibody, or antigen-binding fragment thereof, at an amount of about 50 mg / mL to about 500 mg / mL;(ii) a histidine buffer at an amount of about 1 mM to about 50 mM;(iii) sucrose at an amount of about 1% to about 20% (w / v);(iv) methionine, at an amount of about 0.1 mg / mL to about 10 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1mM to about 500 mM; and(vi) a polysorbate at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5.

51. The pharmaceutical composition of claim 50, wherein the anti-FcRn antibody, or antibody fragment thereof, comprises:(i) a light chain variable region comprising a light chain complementary determining region (CDR) 1 (CDR1) comprising the sequence of SEQ ID NO: 3; a light chain CDR2 comprising the sequence of SEQ ID NO: 4; and a light chain CDR3 comprising the sequence of SEQ ID NO: 5; and (ii) a heavy chain variable region comprising a heavy chain CDR1 comprising the sequence of SEQ ID NO: 6; a heavy chain CDR2 comprising the sequence of SEQ ID NO: 7; and a heavy chain CDR3 comprising the sequence of SEQ ID NO: 8; or variants of any of the foregoing.

52. The pharmaceutical composition of claim 50 or 51, wherein the anti-FcRn antibody comprises a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1.

53. The pharmaceutical composition of any one of claims 50-52, wherein the anti-FcRn antibody comprises a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2.

54. The pharmaceutical composition of any one of claims 50-53, wherein the anti-FcRn antibody comprises: a light chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 1; and a heavy chain comprising a sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO: 2.

55. The pharmaceutical composition of any one of claims 50-54, wherein the anti-FcRn antibody comprises: a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

56. The pharmaceutical composition of any one of claims 50-55, wherein the anti-FcRn antibody is nipocalimab.

57. The pharmaceutical composition of any one of claims 50-56, wherein the anti-FcRn antibody, or antigen-binding fragment thereof, is present at an amount of about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL.

58. The pharmaceutical composition of any one of claims 50-57, wherein the anti-FcRn antibody, or antigen-binding fragment thereof, is present at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

59. The pharmaceutical composition of any one of claims 50-58, wherein the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 50 mM, about 60 mM, about 65 mM, about 70 mM, about 80 mM, about 90 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM.

60. The pharmaceutical composition of any one of claims 50-59, wherein the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM.

61. The pharmaceutical composition of any one of claims 50-60, wherein the pharmaceutical composition comprises a pharmaceutically acceptable salt of arginine, which is arginine hydrochloride.

62. The pharmaceutical composition of any one of claims 50-61, wherein the histidine buffer is present at an amount of about 1 mM to about 40 mM, about 1 mM to about 30 mM, or about 1 mM to about 20 mM.

63. The pharmaceutical composition of any one of claims 50-62, wherein the histidine buffer is present at an amount of about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 11 mM, about 12 mM, about 13 mM, about 14 mM, about 15 mM, about 16 mM, about 17 mM, about 18 mM, about 19 mM, or about 20 mM.

64. The pharmaceutical composition of any one of claims 50-63, wherein the histidine buffer is present at an amount of about 10 mM.

65. The pharmaceutical composition of any one of claims 50-64, wherein the sucrose is present at an amount of about 1% to about 15%, about 2% to about 10%, about 3% to about 10%, about 3% to about 9%, or about 3% to about 8% (w / v).

66. The pharmaceutical composition of any one of claims 50-65, wherein the sucrose is present at an amount of about 1%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about 6.3%, about 6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v).

67. The pharmaceutical composition of any one of claims 50-66, wherein the sucrose is present at an amount of about 3.5%, about 6.4%, or about 8%.

68. The pharmaceutical composition of any one of claims 50-67, wherein the methionine is present at an amount of about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0. 1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0.1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL.

69. The pharmaceutical composition of any one of claims 50-68, wherein the methionine is present at an amount of about 0.1 mg / mL, about 0.2 mg / mL, about 0.3 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.7 mg / mL, about 0.8 mg / mL, about 0.9 mg / mL, about 1mg / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.5 mg / mL, about 1.6 mg / mL, about 1.7 mg / mL, about 1.8 mg / mL, about 1.9 mg / mL, or about 2 mg / mL.

70. The pharmaceutical composition of any one of claims 50-69, wherein the methionine is present at an amount of about 1 mg / mL.

71. The pharmaceutical composition of any one of claims 50-70, wherein the polysorbate is polysorbate 80 (PS80), or polysorbate 20 (PS20).

72. The pharmaceutical composition of any one of claims 50-71, wherein the polysorbate is PS80.

73. The pharmaceutical composition of claim 72, wherein the PS80 is present at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v).

74. The pharmaceutical composition of claim 72 or 73, wherein the PS80 is present at an amount of about 0.005%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% (w / v).

75. The pharmaceutical composition of any one of claims 72-74, wherein the PS80 is present at an amount of about 0.06%.

76. The pharmaceutical composition of any one of claims 50-75, further comprising at least one hyaluronidase enzyme.

77. The pharmaceutical composition of claim 76, wherein the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

78. The pharmaceutical composition of any one of claims 50-77, wherein the pH of the pharmaceutical composition is about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6, about6. 1, about 6.2, about 6.3, about 6.4, or about 6.5.

79. The pharmaceutical composition of any one of claims 1-78, wherein the pH of the pharmaceutical composition is about 6.

80. The pharmaceutical composition of any one of claims 1-79, comprising:(i) an anti-FcRn antibody at an amount of about 50 mg / mL to about 500 mg / mL;(ii) a histidine buffer at an amount of about 1 mM to about 50 mM;(iii) sucrose at an amount of about 1% to about 20% (w / v);(iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and(vi) polysorbate 80 (PS80) at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5; wherein the anti-FcRn antibody comprises a light chain variable region comprising the sequence of SEQ ID NO: 9; and a heavy chain variable region comprising the sequence of SEQ ID NO: 10.

81. The pharmaceutical composition of any one of claims 1-79, comprising:(i) an anti-FcRn antibody at an amount of about 50 mg / mL to about 500 mg / mL;(ii) a histidine buffer at an amount of about 1 mM to about 50 mM;(iii) sucrose at an amount of about 1% to about 20% (w / v);(iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and(vi) polysorbate 80 (PS80) at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5; wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

82. The pharmaceutical composition of any one of claims 1-79, comprising:(i) an anti-FcRn antibody at an amount of about 50 mg / mL to about 500 mg / mL;(ii) a histidine buffer at an amount of about 1 mM to about 50 mM;(iii) sucrose at an amount of about 1% to about 20% (w / v);(iv) methionine at an amount of about 0. 1 mg / mL to about 10 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 1 mM to about 500 mM; and(vi) polysorbate 80 (PS80) at an amount of about 0.001% to about 1% (w / v), and wherein the pH of the pharmaceutical composition is about 5.5 to about 6.5; wherein the anti-FcRn antibody is nipocalimab.

83. The pharmaceutical composition of any one of claims 80-82, wherein the anti-FcRn antibody is present at an amount of about 50 mg / mL to about 250 mg / mL, or about 100 mg / mL to about 250 mg / mL.

84. The pharmaceutical composition of any one of claims 80-83, wherein the anti-FcRn antibody is present at an amount of about 90 mg / mL, about 95 mg / mL, about 100 mg / mL, about 105 mg / mL, about 110 mg / mL, about 115 mg / mL, about 120 mg / mL, about 125 mg / mL, about 130 mg / mL, about 135 mg / mL, about 140 mg / mL, about 145 mg / mL, about 150 mg / mL, about 155 mg / mL, about 160 mg / mL, about 165 mg / mL, about 170 mg / mL, about 175 mg / mL, about 180 mg / mL, about 185 mg / mL, about 190 mg / mL, about 195 mg / mL, about 200 mg / mL, about 205 mg / mL, about 210 mg / mL, about mg / mL, about 220 mg / mL, about 225 mg / mL, about 230 mg / mL, about 235 mg / mL, about 240 mg / mL, about 245 mg / mL, or about 250 mg / mL.

85. The pharmaceutical composition of any one of claims 80-84, wherein the anti-FcRn antibody is present at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

86. The pharmaceutical composition of any one of claims 80-85, wherein the arginine, or the pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 25 mM to about 450 mM, about 50 mM to about 400 mM, about 50 mM to about 350 mM, about 50 mM to about 300 mM, about 50 mM to about 250 mM, or about 50 mM to about 200 mM.

87. The pharmaceutical composition of any one of claims 80-86, wherein the arginine, or the pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 50 mM, about 60 mM, about 65 mM, about 70 mM, about 80 mM, about 90 mM, about 100 mM, about 110 mM, about 120 mM, about 130 mM, about 140 mM, about 150 mM, about 160 mM, about 170 mM, about 180 mM, about 190 mM, or about 200 mM.

88. The pharmaceutical composition of any one of claims 80-87, wherein the arginine, or the pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM.

89. The pharmaceutical composition of any one of claims 80-88, wherein the pharmaceutical composition comprises the pharmaceutically acceptable salt of arginine, which is arginine hydrochloride.

90. The pharmaceutical composition of any one of claims 80-89, wherein the histidine buffer is present at an amount of about 1 mM to about 40 mM, about 1 mM to about 30 mM, or about 1 mM to about 20 mM.

91. The pharmaceutical composition of any one of claims 80-90, wherein the histidine buffer is present at an amount of about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 11 mM, about 12 mM, about 13 mM, about 14 mM, about 15 mM, about 16 mM, about 17 mM, about 18 mM, about 19 mM, or about 20 mM.

92. The pharmaceutical composition of any one of claims 80-91, wherein the histidine buffer is present at an amount of about 10 mM.

93. The pharmaceutical composition of any one of claims 80-92, wherein the sucrose is present at an amount of about 1% to about 15%, about 2% to about 10%, about 3% to about 10%, about 3% to about 9%, or about 3% to about 8% (w / v).

94. The pharmaceutical composition of any one of claims 80-93, wherein the sucrose is present at an amount of about 1%, about 1.1%, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%, about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about 2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%, about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about 3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%, about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about 4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.1%, about 5.2%, about 5.3%, about 5.4%, about 5.5%, about 5.6%, about 5.7%, about 5.8%, about 5.9%, about 6%, about 6.1%, about 6.2%, about 6.3%, about6.4%, about 6.5%, about 6.6%, about 6.7%, about 6.8%, about 6.9%, about 7%, about 7.1%, about 7.2%, about 7.3%, about 7.4%, about 7.5%, about 7.6%, about 7.7%, about 7.8%, about 7.9%, about 8%, about 8.1%, about 8.2%, about 8.3%, about 8.4%, about 8.5%, about 8.6%, about 8.7%, about 8.8%, about 8.9%, about 9%, about 9.1%, about 9.2%, about 9.3%, about 9.4%, about 9.5%, about 9.6%, about 9.7%, about 9.8%, about 9.9%, or about 10% (w / v).

95. The pharmaceutical composition of any one of claims 80-94, wherein the sucrose is present at an amount of about 3.5%, about 6.4%, or about 8%.

96. The pharmaceutical composition of any one of claims 80-95, wherein the methionine is present at an amount of about 0.1 mg / mL to about 9 mg / mL, about 0.1 mg / mL to about 8 mg / mL, about 0.1 mg / mL to about 7 mg / mL, about 0.1 mg / mL to about 6 mg / mL, about 0.1 mg / mL to about 5 mg / mL, about 0. 1 mg / mL to about 4 mg / mL, about 0. 1 mg / mL to about 3 mg / mL, about 0.1 mg / mL to about 2 mg / mL, or about 0.5 mg / mL to about 1.5 mg / mL.

97. The pharmaceutical composition of any one of claims 80-96, wherein the methionine is present at an amount of about 0.1 mg / mL, about 0.2 mg / mL, about 0.3 mg / mL, about 0.4 mg / mL, about 0.5 mg / mL, about 0.6 mg / mL, about 0.7 mg / mL, about 0.8 mg / mL, about 0.9 mg / mL, about 1 mg / mL, about 1.1 mg / mL, about 1.2 mg / mL, about 1.3 mg / mL, about 1.4 mg / mL, about 1.5 mg / mL, about 1.6 mg / mL, about 1.7 mg / mL, about 1.8 mg / mL, about 1.9 mg / mL, or about 2 mg / mL.

98. The pharmaceutical composition of any one of claims 80-97, wherein the methionine is present at an amount of about 1 mg / mL.

99. The pharmaceutical composition of any one of claims 80-98, wherein the PS80 is present at an amount of about 0.005% to about 1% (w / v), about 0.005% to about 0.5% (w / v), about 0.005% to about 0.1% (w / v), about 0.01% to about 0.1% (w / v), about 0.01% to about 0.09% (w / v), or about 0.03% to about 0.09% (w / v).

100. The pharmaceutical composition of any one of claims 80-99, wherein the PS80 is present at an amount of about 0.005%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% (w / v).

101. The pharmaceutical composition of any one of claims 80-100, wherein the PS80 is present at an amount of about 0.06%.

102. The pharmaceutical composition of any one of claims 80-101, further comprising at least one hyaluronidase enzyme.

103. The pharmaceutical composition of claim 102, wherein the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

104. The pharmaceutical composition of any one of claims 80-103, wherein the pH of the pharmaceutical composition is about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6, about 6. 1, about 6.2, about 6.3, about 6.4, or about 6.5.

105. The pharmaceutical composition of any one of claims 80-104, wherein the pH of the pharmaceutical composition is about 6.

106. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL to about 250 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3% to about 8% (w / v);(iv) methionine, at an amount of about 1 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 50 mM to about 200 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising the sequence of SEQ ID NO: 9; and a heavy chain variable region comprising the sequence of SEQ ID NO: 10.

107. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL to about 250 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3% to about 8% (w / v);(iv) methionine, at an amount of about 1 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 50 mM to about 200 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

108. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL to about 250 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3% to about 8% (w / v);(iv) methionine, at an amount of about 1 mg / mL;(v) arginine, or a pharmaceutically acceptable salt thereof, at an amount of about 50 mM to about 200 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody is nipocalimab.

109. The pharmaceutical composition of any one of claims 106-108, wherein the anti-FcRn antibody is present at an amount of about 100 mg / mL, about 185 mg / mL, or about 230 mg / mL.

110. The pharmaceutical composition of any one of claims 106-109, wherein the arginine, or a pharmaceutically acceptable salt thereof, is present in the pharmaceutical composition at an amount of about 65 mM, about 121 mM, or about 150 mM.

111. The pharmaceutical composition of any one of claims 106-110, wherein the pharmaceutically acceptable salt of arginine is arginine hydrochloride.

112. The pharmaceutical composition of any one of claims 105-109, wherein the sucrose is present at an amount of about 3.5%, about 6.4%, or about 8%.

113. The pharmaceutical composition of any one of claims 105-110, further comprising at least one hyaluronidase enzyme.

114. The pharmaceutical composition of claim 111, wherein the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

115. The pharmaceutical composition of any one of claims 105-112, wherein some or all of the amount of anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

116. The pharmaceutical composition of any one of claims 105-113, wherein, in about 0.1-10%, about 0.5-8%, about 0.5-5%, about 1-5%, about 1-4%, about 1-3%, or about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2.

117. The pharmaceutical composition of claim 114, wherein, in about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2.

118. A pharmaceutical composition comprising :(i) an anti-FcRn antibody at an amount of about 185 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 6.4% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 121 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising a CDR LI comprising the sequence of SEQ ID NO: 3, a CDR L2 comprising the sequence of SEQ ID NO: 4, and a CDR L3 comprising the sequence of SEQ ID NO: 5; and a heavy chain variable region comprising a CDR Hl comprising the sequence of SEQ ID NO: 6, a CDR H2 comprising the sequence of SEQ ID NO: 7, and a CDR H3 comprising the sequence of SEQ ID NO: 8.

119. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 185 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 6.4% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 121 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising the sequence of SEQ ID NO: 9; and a heavy chain variable region comprising the sequence of SEQ ID NO: 10.

120. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 185 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 6.4% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 121 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody is nipocalimab.

121. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 185 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 6.4% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 121 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

122. The pharmaceutical composition of claim 119, wherein some or all of the amount of anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

123. The pharmaceutical composition of claim 119 or 120, wherein, in about 0.1-10%, about 0.5- 8%, about 0.5-5%, about 1-5%, about 1-4%, about 1-3%, or about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

124. The pharmaceutical composition of any one of claims 119-121, wherein, in about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

125. The pharmaceutical composition of any one of claims 116-122, wherein the pharmaceutical composition is administered intravenously, is for intravenous administration, or is for use by intravenous administration.

126. The pharmaceutical composition of any one of claims 116-123 for use in the treatment of hemolytic disease of fetus and newborn (HDFN), fetal neonatal alloimmune thrombocytopenia (FNAIT), congenital heart block (CHB), warm autoimmune hemolytic anemia (wAIHA), bullous pemphigoid (BP), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), or idiopathic inflammatory myopathies (IIM).

127. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3.5% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 65 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising a CDR LI comprising the sequence of SEQ ID NO: 3, a CDR L2 comprising the sequence of SEQ ID NO: 4, and a CDR L3 comprising the sequence of SEQ ID NO: 5; and a heavy chain variable region comprising a CDR Hl comprising the sequence of SEQ ID NO: 6, a CDR H2 comprising the sequence of SEQ ID NO: 7, and a CDR H3 comprising the sequence of SEQ ID NO: 8.

128. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3.5% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 65 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising the sequence of SEQ ID NO: 9; and a heavy chain variable region comprising the sequence of SEQ ID NO: 10.

129. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3.5% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 65 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody is nipocalimab.

130. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 100 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 3.5% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 65 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), and wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ IDNO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

131. The pharmaceutical composition of claim 128, wherein some or all of the amount of anti- FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

132. The pharmaceutical composition of claim 128 or 129, wherein, in about 0.1-10%, about 0.5- 8%, about 0.5-5%, about 1-5%, about 1-4%, about 1-3%, or about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2133. The pharmaceutical composition of any one of claims 128-130, wherein, in about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

134. The pharmaceutical composition of any one of claims 125-131 further comprising at least one hyaluronidase enzyme.

135. The pharmaceutical composition of any one of claims 125-132, wherein the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

136. The pharmaceutical composition of any one of claims 125-133, wherein the pharmaceutical composition is administered subcutaneously, is for subcutaneous administration, or is for use by subcutaneous administration.

137. The pharmaceutical composition of any one of claims 125-134, wherein the pharmaceutical composition is administered via an on-body delivery system (OBDS), is for administration via an on-body delivery system (OBDS), or is for use by administration via an on-body delivery system (OBDS).

138. The pharmaceutical composition of any one of claims 125-135 for use in the treatment of warm autoimmune hemolytic anemia (wAIHA), bullous pemphigoid (BP), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), or idiopathic inflammatory myopathies (IIM).

139. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 230 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 8% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 150 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising a CDR LI comprising the sequence of SEQ ID NO: 3, a CDR L2 comprising the sequence of SEQ ID NO: 4, and a CDR L3 comprising the sequence of SEQ ID NO: 5; and a heavy chain variable region comprising a CDR Hl comprising the sequence of SEQ ID NO: 6, a CDR H2 comprising the sequence of SEQ ID NO: 7, and a CDR H3 comprising the sequence of SEQ ID NO: 8.

140. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 230 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 8% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 150 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain variable region comprising the sequence of SEQ ID NO: 9; and a heavy chain variable region comprising the sequence of SEQ ID NO: 10.

141. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 230 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 8% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 150 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody is nipocalimab.

142. A pharmaceutical composition comprising:(i) an anti-FcRn antibody at an amount of about 230 mg / mL;(ii) a histidine buffer at an amount of about 10 mM;(iii) sucrose at an amount of about 8% (w / v);(iv) methionine at an amount of about 1 mg / mL;(v) arginine hydrochloride at an amount of about 150 mM;(vi) a polysorbate 80 (PS80) at an amount of about 0.06% (w / v), wherein the pH of the pharmaceutical composition is about 6; and wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2.

143. The pharmaceutical composition of claim 142, wherein some or all of the amount of anti- FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

144. The pharmaceutical composition of any one of claims 139-143, wherein, in about 0.1-10%, about 0.5-8%, about 0.5-5%, about 1-5%, about 1-4%, about 1-3%, or about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2145. The pharmaceutical composition of any one of claims 139-144, wherein, in about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

146. The pharmaceutical composition of any one of claims 139-145 further comprising at least one hyaluronidase enzyme.

147. The pharmaceutical composition of claim 146, wherein the hyaluronidase enzyme is selected from the group consisting of PH20, modified PH20, xeno-derived hyaluronidase, recombinant human hyaluronidase (rHuPH20), ovine PH20, and bovine PH20.

148. The pharmaceutical composition of any one of claims 139-147, wherein the pharmaceutical composition is administered subcutaneously, is for subcutaneous administration, or us for use by subcutaneous administration.

149. The pharmaceutical composition of any one of claims 139-148, wherein the pharmaceutical composition is formulated for administration via a pre-filled syringe (PFS).

150. The pharmaceutical composition of any one of claims 139-149 for use in the treatment of rheumatoid arthritis, Sjogren’s disease, systemic lupus erythematosus, and lupus nephritis.

151. A pharmaceutical composition comprising an amount of an anti-FcRn antibody, wherein the anti-FcRn antibody comprises a light chain comprising the sequence of SEQ ID NO: 1; and a heavy chain comprising the sequence of SEQ ID NO: 2, wherein, in about 0.1-10%, about 0.5-8%, about 0.5-5%, about 1-5%, about 1-4%, about 1- 3%, or about 1-2% of the amount of anti-FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C-terminus of SEQ ID NO: 2.

152. The pharmaceutical composition of claim 151, wherein in about 1-2% of the amount of anti- FcRn antibody, the anti-FcRn antibody further comprises an additional lysine residue at the C- terminus of SEQ ID NO: 2.

153. The pharmaceutical composition of any one of claims 1-152, wherein the pharmaceutical composition comprises a viscosity at about 25°C of less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP.

154. The pharmaceutical composition of any one of claims 1-152, wherein the pharmaceutical composition comprises a viscosity at about 25°C of less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP, after storage for about 24 months or more and at a temperature of about 5 °C.

155. The pharmaceutical composition of any one of claims 1-152, wherein the formulation has a viscosity at about 25°C of less than about 40 cP, less than about 30 cP, less than about 25 cP, or as less than about 20 cP, after storage for about 12 months or more and at a temperature of about 25 °C.

156. The pharmaceutical composition of any one of claims 1-155, wherein the pharmaceutical composition is for intravenous or subcutaneous administration, or is for use by intravenous or subcutaneous administration.

157. The pharmaceutical composition of any one of claims 1-156, wherein the pharmaceutical composition is administered, or is for administration, or is for use by administration, using an infusion pump, a patch pump, an autoinjector, a wearable injector, or an on-body delivery system (OBDS).

158. The pharmaceutical composition of any one of claims 1-157, wherein the pharmaceutical composition is a liquid pharmaceutical composition.

159. The pharmaceutical composition of any one of claims 1-158, wherein the pharmaceutical composition is stable at a temperature of about 2-8°C after at least six months, after at least one year, or after at least two years.

160. The pharmaceutical composition of claim 159, wherein stability is defined based on color of solution, pH, turbidity, percentage of main component (MC), percentage of high molecular weight species (HMWS), percentage of low molecular weight species (LMWS), percentage of sum of acidic peaks, percentage of sum of basic peaks, protein concentration, or any combination thereof.

161. The pharmaceutical composition of claim 159 or 160, wherein stability is defined as having at least about 98% of the MC after about 6 months of storage at about 5°C.

162. The pharmaceutical composition of claim 159 or 160, wherein stability is defined as having at least about 95% of the MC after about 12 months of storage at about 5°C.

163. The pharmaceutical composition of claim 159 or 160, wherein stability is defined as having at least about 90% of the MC after about 24 months of storage at about 5°C.

164. The pharmaceutical composition of claim 159 or 160, wherein stability is defined as having a pH range of 5.5 to about 6.5 after storage for about 24 months or more and at a temperature of about 5 °C.

165. The pharmaceutical composition of claim 159 or 160, wherein stability is defined as having a pH range of 5.5 to about 6.5 after storage for about 12 months or more and at a temperature of about 25 °C.

166. The pharmaceutical composition of any one of claim 157-165, wherein stability is defined as having a HMWS of about 5.0% or less after storage for about 24 months or more and at a temperature of about 5 °C.

167. The pharmaceutical composition of claim 157-165, wherein stability is defined as having a HMWS of about 5.0% or less after storage for about 12 months or more and at a temperature of about 25 °C.

168. A pharmaceutical product comprising the pharmaceutical composition of any one of claims 1-167 in a container.

169. The pharmaceutical product of claim 168, wherein the container is a plastic vial, glass vial, or cartridge.

170. The pharmaceutical product of claim 168, wherein the container is a pre-filled syringe (PFS).

171. The pharmaceutical product of claim 168, wherein the container is an autoinjector.

172. A kit, comprising the pharmaceutical composition of any one of claims 1-167, or the pharmaceutical product of any one of claims 168-171 and instructions for use.

173. A method of treating a disease, said method comprising administering to a subject a pharmaceutical composition of any one of claims 1-167.

174. The pharmaceutical composition of any one of claims 1-167 for use in treating a disease, the use comprising administering to a subject the pharmaceutical composition.

175. The method of claim 173 or the pharmaceutical composition for the use of claim 172, wherein the disease is an immune disease selected from the group consisting of lupus nephritis, myasthenia gravis, autoimmune hemolytic anemia (AIHA), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjogren’s disease, systemic lupus erythematosus, bullous pemphigoid, idiopathic inflammatory myopathies, and rheumatoid arthritis.

176. The method of claim 173 or the pharmaceutical composition of the use of claim 174, wherein the disease is a maternal fetal indication selected from the group consisting of hemolytic disease of the fetus and newborn (HDFN), congenital heart block (CHB), and fetal and neonatal alloimmune thrombocytopenia (FNAIT).

177. A method for preparing a formulation, the method comprising the steps of: a) providing an input solution comprising one or more proteins; b) subjecting the input solution to diafdtration, using a diafdtration solution, until at least an 8-fold to 12-fold volume exchange with the diafdtration solution has been achieved, thereby forming an output solution; and c) concentrating said one or more proteins in the output solution within a range of about 150 to about 250 mg / mL.

178. The method of claim 177, wherein the diafdtration solution comprises:(i) a histidine buffer at an amount of about 15.2 mM;(ii) sucrose at an amount of about 10.7% (w / v);(iii) methionine at an amount of about 1.45 mg / mL;(iv) arginine hydrochloride at an amount of about 195 mM; wherein the pH of the diafdtration solution is about 6.

179. The method of claim 177 or 178, wherein the input solution further comprises:(i) acetate at 100 mM;(ii) NaCl at 75 mM; wherein the pH of the input solution is about 5.5.

180. The method of any one of claims 177-179, wherein the one or more proteins is an antibody, or antigen binding fragment thereof.

181. The method of claim 180, wherein the antibody, or antigen-binding fragment thereof, is an anti-FcRn antibody.

182. A formulation prepared according to the method of any one of claims 177-181.

183. A diafiltration solution comprising:(i) a histidine buffer at an amount of about 15.2 mM;(ii) sucrose at an amount of about 10.7% (w / v);(iii) methionine at an amount of about 1.45 mg / mL;(iv) arginine hydrochloride at an amount of about 195 mM; wherein the pH of the diafdtration solution is about 6.

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