Pharmaceutical compositions containing anti-human TSLP receptor antibodies and methods of using the same

Abstract

Pharmaceutical compositions of anti-TSLP-R antibodies and uses thereof are provided herein. Pharmaceutical compositions can include, for example, an anti-TSLP-R antibody, or an antigen-binding fragment thereof, pharmaceutically acceptable buffers, excipients, and surfactants, or other compositions as provided herein.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of, and claims priority to, PCT Application No. PCT / CN2022 / 130252, filed November 7, 2022, which claims priority to U.S. Provisional Patent Application Nos. 63 / 508,564, filed June 16, 2023, and 63 / 591,238, filed October 18, 2023, each of which is incorporated by reference herein in its entirety.

[0002] Reference to an electronically submitted sequence listing This application contains a Sequence Listing that has been submitted electronically in XML file format, which is incorporated herein by reference in its entirety. The XML copy, created on November 3, 2023, is named "UPS-003WO2_SL.XML" and is 14,288 bytes in size.

[0003] Field Embodiments provided herein relate to antibodies, and fragments thereof, that bind to thymic stromal lymphopoietin receptor (TSLP-R), and pharmaceutical compositions comprising the same. [Background technology]

[0004] Thymic stromal lymphopoietin (TSLP) is an epithelial cell-derived cytokine produced in response to inflammatory stimuli. It is involved in dendritic cell-mediated Th2 cell activation and interacts with the TSLP receptor (TSLP-R). TSLP-mediated activation of dendritic cells via the TSLP-R has been reported to be involved in various disease pathologies, including allergic inflammation and chronic obstructive pulmonary disease, autoimmune and rheumatic diseases, cancer, coronary artery disease, and myocardial infarction. Therefore, monoclonal antibodies that specifically bind to human TSLP-R and inhibit the action of human TSLP through the human TSLP-R are useful for preventing and treating various diseases in which human TSLP and the human TSLP-R are involved in the disease pathology. There is a need for improved formulations of pharmaceutical compositions containing TSLP-R-specific antibodies and fragments thereof. There is also a need for methods of treating TSLP-mediated pathologies using pharmaceutical compositions containing TSLP-R-specific antibodies and fragments thereof. The present embodiments address these and other needs. Summary of the Invention

[0005] The disclosed embodiments are directed to antibodies, or antibody fragments thereof, that specifically bind to TSLP-R, and pharmaceutical compositions containing antibodies and fragments thereof specific for TSLP-R.

[0006] Embodiments provided herein are directed to pharmaceutical compositions comprising an anti-TSLP-R antibody or antigen-binding fragment thereof. In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) an excipient at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0007] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0008] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0009] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0010] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a histidine buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) glycine at a concentration of about 1 mmol / L to about 600 mmol / L, or a pharmaceutically acceptable salt thereof; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0011] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a histidine buffer solution at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0012] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a histidine buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0013] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 150 mg / mL to about 250 mg / mL; (ii) a histidine buffer at a concentration of about 10 mmol / L to about 30 mmol / L; (iii) glycine at a concentration of about 100 mmol / L to about 200 mmol / L, or a pharmaceutically acceptable salt thereof; and (iv) polysorbate 80 at a concentration of about 0.01% to about 0.2% (w / v).

[0014] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 150 mg / mL to about 250 mg / mL; (ii) a histidine buffer solution at a concentration of about 10 mmol / L to about 30 mmol / L; (iii) arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 150 mmol / L; and (iv) polysorbate 80 at a concentration of about 0.01% to about 0.2% (w / v).

[0015] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody or antigen-binding fragment thereof at a concentration of about 150 mg / mL to about 250 mg / mL; (ii) a histidine buffer at a concentration of about 10 mmol / L to about 30 mmol / L; (iii) proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 220 mmol / L; and (iv) polysorbate 80 at a concentration of about 0.01% to about 0.2% (w / v).

[0016] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 180 mg / mL to about 220 mg / mL; (ii) a histidine buffer at a concentration of about 18 mmol / L to about 22 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0017] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 135 mg / mL to about 165 mg / mL; (ii) a histidine buffer at a concentration of about 18 mmol / L to about 22 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0018] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 180 mg / mL to about 220 mg / mL; (ii) a histidine buffer at a concentration of about 18 mmol / L to about 22 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 105 mmol / L to 135 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0019] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 135 mg / mL to about 165 mg / mL; (ii) a histidine buffer at a concentration of about 18 mmol / L to about 22 mmol / L; (iii) arginine at a concentration of about 105 mmol / L to 135 mmol / L, or a pharmaceutically acceptable salt thereof; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0020] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 180 mg / mL to about 220 mg / mL; (ii) a histidine buffer at a concentration of about 18 mmol / L to about 22 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0021] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 135 mg / mL to about 165 mg / mL; (ii) a histidine buffer at a concentration of about 18 mmol / L to about 22 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0022] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0023] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.02% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0024] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL, (ii) a histidine buffer at a concentration of about 20 mmol / L, (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L, (iv) polysorbate 80 at a concentration of about 0.03% (w / v), and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0025] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL, (ii) a histidine buffer at a concentration of about 20 mmol / L, (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L, (iv) polysorbate 80 at a concentration of about 0.02% (w / v), and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0026] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.04% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0027] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0028] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.02% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0029] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L; (iv) polysorbate 80 at a concentration of about 0.02% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0030] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.04% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0031] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0032] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.02% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0033] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0034] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.02% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0035] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0036] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.02% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0037] In some embodiments, the pharmaceutical composition comprises (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; and (b) a heavy chain variable region comprising a heavy chain CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0038] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; and, optionally,

[0039] (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L, (iii) an excipient at a concentration of about 1 mmol / L to about 600 mmol / L, and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0040] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; (ii) a histidine buffer at a concentration of 18 mmol / L to 22 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of 160 mmol / L to 200 mmol / L; (iv) polysorbate 80 at a concentration of 0.01% (w / v) to 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CD and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0041] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; (b) a heavy chain variable region comprising a CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising a light chain CDR1, CDR2, and CDR3 sequence, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0042] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; (ii) a histidine buffer at a concentration of 18 mmol / L to 22 mmol / L; (iii) arginine at a concentration of 105 mmol / L to 135 mmol / L, or a pharmaceutically acceptable salt thereof; (iv) polysorbate 80 at a concentration of 0.01% (w / v) to 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain C and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0043] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; (b) a heavy chain variable region comprising a CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising a light chain CDR1, CDR2, and CDR3 sequence, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0044] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; (ii) a histidine buffer at a concentration of 18 mmol / L to 22 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of 160 mmol / L to 200 mmol / L; (iv) polysorbate 80 at a concentration of 0.01% (w / v) to 0.05% (w / v); and (v) a pH of about 5.6 to 5.8, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CD and (b) a heavy chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0045] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of about 0.03 mg / kg to about 10 mg / kg; (ii) a histidine buffer at a concentration of about 20 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises: (a) a heavy chain CDR1, CDR2, and CDR3 sequence; (b) a heavy chain variable region comprising a CDR1 sequence having the amino acid sequence of SEQ ID NO: 7, a heavy chain CDR2 sequence having the amino acid sequence of SEQ ID NO: 8, and a heavy chain CDR3 sequence having the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising a light chain CDR1, CDR2, and CDR3 sequence, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12.

[0046] In some embodiments, provided herein is a pharmaceutical dosage form of a pharmaceutical composition. In some embodiments, the pharmaceutical dosage form comprises a pharmaceutical composition in a container.

[0047] In some embodiments, a kit is provided herein. In some embodiments, the kit comprises a pharmaceutical composition as disclosed herein and instructions for use. In some embodiments, the kit further comprises a pharmaceutical dosage form of the pharmaceutical composition, wherein the pharmaceutical dosage form comprises the pharmaceutical composition in a container. In some embodiments, the container is a pre-filled syringe, a plastic vial, or a glass vial.

[0048] In some embodiments, methods of treating a disease in a subject in need thereof are provided, hi some embodiments, the methods comprise administering a therapeutically effective amount of a pharmaceutical composition or a pharmaceutical dosage form of a pharmaceutical composition as disclosed herein.

[0049] In some embodiments, methods are provided for treating or reducing the severity of a disease in a subject in need thereof, hi some embodiments, the methods comprise administering a therapeutically effective amount of a pharmaceutical composition or a pharmaceutical dosage form of a pharmaceutical composition.

[0050] In some embodiments, methods are provided for delaying the onset of a disease in a subject in need thereof, hi some embodiments, the methods comprise administering a therapeutically effective amount of a pharmaceutical composition or a pharmaceutical dosage form of a pharmaceutical composition.

[0051] In some embodiments, methods of preventing a disease in a subject in need thereof are provided, hi some embodiments, the methods comprise administering a therapeutically effective amount of a pharmaceutical composition or a pharmaceutical dosage form of a pharmaceutical composition.

[0052] In some embodiments, methods are provided for increasing the internalization of TSLP-R on cells, which methods include contacting the cells with a pharmaceutical composition or a pharmaceutical dosage form of the pharmaceutical composition.

[0053] In some embodiments, methods for inhibiting TSLP-R on a cell are provided, which include contacting the cell with a pharmaceutical composition or a pharmaceutical dosage form of the pharmaceutical composition.

[0054] In some embodiments, methods are provided for inhibiting TSLP-R by at least 95%, 96%, 97%, 98%, or 99% or 100% in a subject in need thereof. In some embodiments, the methods comprise administering a pharmaceutical composition or a pharmaceutical dosage form of the pharmaceutical composition. [Brief explanation of the drawings]

[0055] [Figure 1A]Data showing that TRAB-1 produces potent suppression of TSLP / TSLP-R-mediated responses in vitro. Chart showing cell proliferation rate in Ba / F3 cells transfected with human TSLP-R / IL-7Rα and treated with either TRAB-1 antibody, tezepelumab antibody, or IgG antibody, plotted as a function of antibody concentration. [Figure 1B] Data showing that TRAB-1 produces potent suppression of TSLP / TSLP-R-mediated responses in vitro. Bar graph showing CCL17 (ng / mL) production in dendritic cells treated with TRAB-1 antibody, tezepelumab antibody, or IgG antibody, plotted as a function of antibody concentration. [Figure 2A] Data showing that a single ascending dose (SAD) study in healthy volunteers demonstrated sustained pharmacokinetic (PK) efficacy over 60 days. Graph showing mean serum concentrations over time as a function of TRAB-1 dose and route of administration. IV = intravenous, SC = subcutaneous. [Figure 2B] Data showing that a single ascending dose (SAD) study in healthy volunteers demonstrated sustained pharmacokinetic (PK) efficacy over 60 days. Graph showing predicted mean serum concentrations of TRAB-1 over time as a function of dose of TRAB-1 administered subcutaneously every 4 weeks. [Figure 2C] Data showing that a single ascending dose (SAD) study in healthy volunteers demonstrated sustained pharmacokinetic (PK) efficacy over 60 days. Graph showing predicted mean serum concentrations of TRAB-1 over time as a function of dose of TRAB-1 administered subcutaneously every 12 weeks. [Figure 3A] Data showing that a decrease in eosinophils was evident after a single dose of TRAB-1 in healthy volunteers. Graph showing eosinophil concentration as a function of time in healthy volunteers treated with 20 mg (0.3 mg / kg) or more of TRAB-1. Groups were selected based on eosinophil concentration on day 0: <150 cells / μL and >150 cells / μL. [Figure 3B]Data showing that eosinophil reduction was evident after a single dose of TRAB-1 in healthy volunteers. Graph showing eosinophil concentrations as a function of time in healthy volunteers treated with 20 mg (0.3 mg / kg) or more of TRAB-1 compared to the placebo group. Groups were selected based on eosinophil concentrations on day 0: <150 cells / μL (n=17), 150-200 cells / μL (n=3), 200-300 cells / μL (n=5), and >300 cells / μL (n=5). [Figure 4A] Data showing indices of pharmacokinetic / pharmacodynamic correlation in healthy volunteers treated with single ascending doses of TRAB-1. Pharmacokinetic curves showing mean serum TRAB-1 as a function of time in healthy volunteers treated with 2 mg, 7 mg, 20 mg, 70 mg, 210 mg, or 700 mg of TRAB-1. [Figure 4B] Data showing indications of pharmacokinetic / pharmacodynamic correlation in healthy volunteers treated with single ascending doses of TRAB-1. Pharmacodynamic curves showing eosinophils as a function of time in healthy volunteers treated with 2 mg and 7 mg, or 20 mg and 70 mg of TRAB-1. [Figure 5] Data showing mean serum concentrations of TRAB-1 for up to 32 weeks in asthmatic subjects administered TRAB-1 by subcutaneous (SC) injection. Subjects receiving TRAB-1 included Group 1, who received 100 mg of TRAB-1 every 4 weeks for a total of three doses and were monitored for up to 32 weeks; Group 2, who received 200 mg of TRAB-1 for a total of two doses and were monitored for up to 24 weeks; and Group 3, who received 300 mg of TRAB-1 for a total of one dose and were monitored for up to 24 weeks. The observed serum concentrations are compared to those predicted by the model shown in Figure 2B and are shown as solid lines. [Figure 6]Data showing TSLP-R occupancy over time in asthmatic subjects receiving placebo or TRAB-1 by subcutaneous (SC) injection. The placebo group received a single dose of placebo, and the percentage of free TSLP receptors was monitored for 24 weeks. For subjects receiving TRAB-1, group 1 received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, and receptor occupancy was monitored for up to 24 weeks. group 2 received 200 mg of TRAB-1 for a total of one, two, or three doses, and receptor occupancy was monitored for up to 24 weeks. group 3 received 300 mg of TRAB-1 for a total of one or two doses, and receptor occupancy was monitored for up to 24 weeks. group 4 received a single dose of 25 mg of TRAB-1, and receptor occupancy was monitored for up to 20 weeks. [Figure 7A] Data showing blood eosinophil concentrations over time in asthmatic subjects receiving placebo or TRAB-1 by subcutaneous (SC) injection. Subjects receiving TRAB-1 included Group 1, who received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, with eosinophil concentrations monitored for up to 24 weeks; Group 2, who received 200 mg of TRAB-1 for a total of one, two, or three doses, with eosinophil concentrations monitored for up to 24 weeks; Group 3, who received 300 mg of TRAB-1 for a total of one or two doses, with eosinophil concentrations monitored for up to 24 weeks; and Group 4, who received a single dose of 25 mg of TRAB-1, with receptor occupancy monitored for up to 20 weeks. Graph showing mean blood eosinophil concentrations (cells / μL) over time. Error bars represent standard error of the mean. [Figure 7B]Data showing blood eosinophil concentrations over time in asthmatic subjects receiving placebo or TRAB-1 by subcutaneous (SC) injection. Subjects receiving TRAB-1 included Group 1, who received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, with eosinophil concentrations monitored for up to 24 weeks; Group 2, who received 200 mg of TRAB-1 for a total of one, two, or three doses, with eosinophil concentrations monitored for up to 24 weeks; Group 3, who received 300 mg of TRAB-1 for a total of one or two doses, with eosinophil concentrations monitored for up to 24 weeks; and Group 4, who received a single dose of 25 mg of TRAB-1, with receptor occupancy monitored for up to 20 weeks. Graph showing change over time in mean blood eosinophil concentrations (cells / μL) compared to baseline levels. Error bars represent standard error of the mean. The dashed line represents the maximum known treatment response to tezepelumab (Ly et al., J Clin Pharm 2021). [Figure 7C] Data showing blood eosinophil concentrations over time in asthmatic subjects receiving placebo or TRAB-1 by subcutaneous (SC) injection. Subjects receiving TRAB-1 included Group 1, who received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, with eosinophil concentrations monitored for up to 24 weeks; Group 2, who received 200 mg of TRAB-1 for a total of one, two, or three doses, with eosinophil concentrations monitored for up to 24 weeks; Group 3, who received 300 mg of TRAB-1 for a total of one or two doses, with eosinophil concentrations monitored for up to 24 weeks; and Group 4, who received a single dose of 25 mg of TRAB-1, with receptor occupancy monitored for up to 20 weeks. Graph showing the percentage change in mean blood eosinophil concentrations over time compared to baseline levels. Error bars represent standard error of the mean. The dashed line represents the maximum known treatment response to tezepelumab (Ly et al., J Clin Pharm 2021). [Figure 8A]Data showing exhaled nitric oxide (FeNO) levels over time in asthmatic subjects receiving placebo or TRAB-1 by subcutaneous (SC) injection. Among subjects receiving TRAB-1, Group 1 received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses and monitored FeNO for up to 32 weeks; Group 2 received 200 mg of TRAB-1 for a total of one, two, or three doses and monitored FeNO for up to 24 weeks; Group 3 received 300 mg of TRAB-1 for a total of one or two doses and monitored FeNO for up to 24 weeks; and Group 4 received a single dose of 25 mg of TRAB-1 and monitored FeNO for up to 24 weeks. Graph showing mean FeNO (ppb) over time. Error bars represent standard error of the mean. [Figure 8B] Data showing exhaled nitric oxide (FeNO) levels over time in asthmatic subjects receiving placebo or TRAB-1 by subcutaneous (SC) injection. Among subjects receiving TRAB-1, Group 1 received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, and FeNO was monitored for up to 32 weeks; Group 2 received 200 mg of TRAB-1 for a total of one, two, or three doses, and FeNO was monitored for up to 24 weeks; Group 3 received 300 mg of TRAB-1 for a total of one or two doses, and FeNO was monitored for up to 24 weeks; and Group 4 received a single dose of 25 mg of TRAB-1 for up to 24 weeks. Graph showing change in mean FeNO (ppb) over time compared to baseline levels. Error bars represent standard error of the mean. The dashed line represents the maximum known treatment response to tezepelumab (Ly et al., J Clin Pharm 2021. Jul;61(7):901-912). [Figure 8C]Data showing exhaled nitric oxide (FeNO) levels over time in asthmatic subjects receiving placebo or TRAB-1 via subcutaneous (SC) injection. Among subjects receiving TRAB-1, Group 1 received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, and FeNO was monitored for up to 32 weeks; Group 2 received 200 mg of TRAB-1 for a total of one, two, or three doses, and FeNO was monitored for up to 24 weeks; Group 3 received 300 mg of TRAB-1 for a total of one or two doses, and FeNO was monitored for up to 24 weeks; and Group 4 received a single dose of 25 mg of TRAB-1 for up to 24 weeks. Graph showing the percentage change in mean FeNO over time for Groups 1, 2, 3, and 4 compared to baseline levels. Error bars represent the standard error of the mean. The dashed line represents the maximum known treatment response to tezepelumab (Ly et al., J Clin Pharm 2021. Jul;61(7):901-912). [Figure 8D] Data showing exhaled nitric oxide (FeNO) levels over time in asthmatic subjects receiving placebo or TRAB-1 via subcutaneous (SC) injection. Among subjects receiving TRAB-1, Group 1 received 100 mg of TRAB-1 every 4 weeks for a total of two or three doses, and FeNO was monitored for up to 32 weeks; Group 2 received 200 mg of TRAB-1 for a total of one, two, or three doses, and FeNO was monitored for up to 24 weeks; Group 3 received 300 mg of TRAB-1 for a total of one or two doses, and FeNO was monitored for up to 24 weeks; and Group 4 received a single dose of 25 mg of TRAB-1 for up to 24 weeks. Graph showing the percentage change in mean FeNO over time for Groups 1 and 4 compared to baseline levels. Error bars represent the standard error of the mean. [Figure 9A]Graph showing pharmacokinetic / pharmacodynamic model of TRAB-1 serum concentrations in patients treated with various TRAB-1 regimens. The pharmacokinetic / pharmacodynamic model shows TRAB-1 serum concentrations in patients treated with 25 mg or 100 mg of TRAB-1 every 12 weeks. The threshold concentrations of TRAB-1 required for a 50% response (EC50), 80% response (EC80), and 90% response (EC90) in FeNO based on the MAD study are shown. Also shown is the IC90 value, which represents the predicted trough concentration based on the SAD study of approximately 0.3 μg / mL. [Figure 9B] Graph showing pharmacokinetic / pharmacodynamic model of TRAB-1 serum concentrations in patients treated with various regimens of TRAB-1. The pharmacokinetic / pharmacodynamic model shows TRAB-1 serum concentrations in patients treated with 400 mg of TRAB-1 every 24 weeks. The threshold concentrations of TRAB-1 required for a 50% response (EC50), 80% response (EC80), and 90% response (EC90) in FeNO based on the MAD study are shown. Also shown is the IC90 value, which represents the predicted trough concentration based on the SAD study of approximately 0.3 μg / mL. DETAILED DESCRIPTION OF THE INVENTION

[0056] Detailed Description Provided herein are antibodies, or antigen-binding fragments thereof, that bind to and modulate the activity of TSLP-R.

[0057] It is to be understood that the embodiments described herein are not limited to the particular formulations, compositions, and experimental conditions disclosed, as such formulations, compositions, and experimental conditions may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0058] Furthermore, unless otherwise indicated, the formulations, compositions, and experimental conditions described herein use conventional molecular and cell biological and immunological techniques known within the skill of those skilled in the art. Such techniques are well known to those skilled in the art and are fully described in the literature. See, for example, Ausubel, et al., ed., Current Protocols in Molecular Biology, John Wiley & Sons, Inc., NY, NY (1987-2008), M.R. Green and J. Sambrook, Molecular Cloning: A Laboratory Manual (Fourth Edition), and Harlow et al., Antibodies: A Laboratory Manual, Chapter 14, Cold Spring Harbor Laboratory, Cold Spring Harbor (2013, 2nd Edition), including all appendices.

[0059] Unless otherwise specified, all technical and scientific terms have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosed embodiments belong. In describing the methods of the present disclosure and how to use them, certain terms are described below, or elsewhere in this specification, to provide additional guidance to the practitioner. It will be understood, further, that the same thing can be said in multiple ways. Accordingly, alternative language and synonyms may be used for any one or more of the terms described herein, and no special significance is attached to whether a term is detailed or described herein. Synonyms for certain terms are provided. The listing of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification, including examples of any term described herein, is illustrative only and in no way limits the scope and meaning of the disclosure or any exemplified term. Similarly, the present disclosure is not limited to its preferred embodiments.

[0060] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0061] In order that this disclosure may be more readily understood, selected terms are defined.

[0062] The articles "a," "an," and "the" are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an animal" means one animal (one species) or two or more animals (two species).

[0063] As used herein, the adverb "about" or "approximately" means that a numerical value is approximate and that small variations will not significantly affect the practice of the disclosed embodiments. When numerical limitations are used, unless the context dictates otherwise, "about" means that the numerical value can vary by ±5% and still remain within the scope of the disclosed embodiments. Thus, about 100 means 95 to 105.

[0064] As used herein, the irregular verb "has" and its conjugations, as well as the verbs "comprise," "include," and "contain" and their conjugations, mean "including, but not limited to." As used herein, the term "including, but not limited to" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Although various compositions and methods are described in terms "comprising" (which is interpreted to mean "including, but not limited to") various components or steps, the compositions, methods, and devices can also "consist essentially of" or "consist of" the various components and steps, and such terminology should be interpreted as defining an essentially exclusive group of members.

[0065] As used herein, the term "antibody" refers to any form of antibody that exhibits the desired biological activity. Thus, the term is used in the broadest sense and specifically encompasses, but is not limited to, monoclonal antibodies (including full-length monoclonal antibodies), polyclonal antibodies, multispecific antibodies (e.g., bispecific antibodies), humanized antibodies, fully human antibodies, chimeric antibodies, and camelized single-domain antibodies. Another word for antibody is "immunoglobulin." An antibody can immunospecifically bind to one or more epitopes or antigen-binding sites. As used herein, the assignment of amino acids to each domain within an antibody follows the Kabat numbering system.

[0066] As used herein, unless otherwise indicated, "antibody fragment" or "antigen-binding fragment" refers to an antigen-binding fragment of an antibody, i.e., an antibody fragment that retains the ability to specifically bind to the antigen bound by the full-length antibody, e.g., a fragment that retains one or more CDR regions. Examples of antibody-binding fragments include, but are not limited to, Fab, Fab', F(ab')2, and Fv fragments, diabodies, linear antibodies, single-chain antibody molecules such as sc-Fv, nanobodies, and multispecific antibody fragments.

[0067] The term "antigen," as used herein, means any molecule capable of generating an antibody, either directly or indirectly. "Antigen" can also refer to the binding partner of an antibody, or a fragment thereof. Included within the definition of "antigen" is a protein-encoding nucleic acid.

[0068] The terms "epitope" and "antigen-binding site" are intended to refer to the portion of any molecule capable of being recognized and bound by an antibody, or a fragment thereof, at one or more of the antigen-binding regions of the Ab. Epitopes typically consist of chemically active surface groupings of molecules, such as amino acids or sugar side chains, and have specific charge characteristics as well as specific three-dimensional structural characteristics. Examples of epitopes include, but are not limited to, the residues described herein that form the TSLP-R epitope.

[0069] As used herein, the terms "specific binding," "immunospecific binding," "immunospecific binding," and the like are used interchangeably and refer to an antibody, or fragment thereof, that binds to a given antigen (e.g., TSLP-R) or an epitope present on the antigen. The degree of specific binding between an antibody, or fragment thereof, and its antigen can be quantified by the dissociation constant (KD), which is an equilibrium constant that measures the tendency of a complex to dissociate into smaller components. Typical KDs for antibodies bound to antigens are about 10-9 M to about 10-6 M or less. An antibody can be defined as "specific" for a given antigen if the KD between the antibody and the given antigen is at least twice the KD between the antibody and a nonspecific antigen (e.g., BSA, casein, or another nonspecific polypeptide). An antibody can be said to have "high specific binding" to a given antigen if the KD between the antibody and the given antigen is about 10-9 M or greater. Methods for determining mAb specificity and affinity by competitive inhibition can be found in Harlow, et al., Antibodies: A Laboratory Manual, Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, 1988), Colligan et al., eds., Current Protocols in Immunology, Greene Publishing Assoc. and Wiley Interscience, NY, (1992, 1993), and Muller, Meth. Enzymol. 92:589 601 (1983), which are incorporated herein by reference in their entireties.

[0070] The terms "purified" or "isolated" mean changed or removed from the natural state. When referring to an antibody, or fragment thereof, the term refers to an antibody, or fragment thereof, that is substantially free of other materials that associate with the molecule in its natural environment. For example, a purified protein is substantially free of cellular material or other proteins from the cell or tissue from which it is derived. The term refers to a preparation where the isolated protein is sufficiently pure to be analyzed or is at least 70%-80% (w / w) pure, at least 80%-90% (w / w) pure, at least 90%-95% (w / w) pure, at least 95% pure (w / w), at least 96% pure (w / w), at least 97% pure (w / w), at least 98% pure (w / w), at least 99% pure (w / w), or 100% pure (w / w).

[0071] As used herein, the term "encoding" refers to the inherent property of a polynucleotide, e.g., a gene, cDNA, or specific sequence of nucleotides, such as mRNA or viral RNA, to serve as a template for the synthesis of other polymers and macromolecules in biological processes, having either a defined sequence of nucleotides (i.e., rRNA, tRNA, and mRNA) or a defined sequence of amino acids, and the biological properties resulting therefrom. Thus, a gene encodes a protein when the protein is produced in a cell or other biological system by transcription and translation of the mRNA corresponding to that gene. Both the coding strand, whose nucleotide sequence is identical to the mRNA sequence and is usually provided in a sequence listing, and the non-coding strand, which is used as a template for transcription of the gene or cDNA, can be said to encode the protein or other product of that gene or cDNA.

[0072] As used herein, the term "homologue" refers to a protein sequence that shares 40% to 100% sequence identity with a reference sequence. The percent identity between two peptide chains can be determined by pairwise alignment using the default settings of the AlignX module in Vector NTI v.9.0.0 (Invitrogen Corp., Carlsbad, Calif.).

[0073] Anti-TSLP-R antibody This disclosure may refer to TSLP and TSLP-R, another name for TSLP-R is cytokine receptor-like factor 2 (CRLF2).

[0074] TSLP is a cytokine produced and secreted by epithelial cells in response to inflammatory stimuli. Without wishing to be bound by any particular theory, TSLP enhances allergic inflammatory responses through activation of dendritic cells and mast cells. TSLP activates dendritic cells by binding to the TSLP-R / IL7R-α heterodimer, which consists of one TSLP-R and one IL-7 receptor α chain (IL7R-α). TSLP-activated dendritic cells induce the differentiation of naive T cells into Th2 cells and express proinflammatory cytokines that attract Th2 cells to the inflammatory site ( Nat. Immunol., 2002, Vol. 7, pp. 673-680; Int. Immunol., 1999, Vol. 11, pp. 81-88). Inflammatory responses mediated by TSLP-activated dendritic cells have been reported to be involved in the pathology of several diseases, including allergic inflammatory diseases such as asthma and systemic sclerosis ( Nat. Immunol., 2005, Vol. 6, pp. 1047-1053 ). Loss of TSLP-R is associated with suppression of Th2 cytokines and IgE production in the blood of TSLP-R knockout mouse models, and the use of anti-TSLP-R antibodies in mouse models of asthma is also associated with improved respiratory function ( J. Exp. Med., 2005, Vol. 202, pp. 829-839 and Clin. Immunol., 2008, Vol. 129, pp. 202-210 ). Therefore, antibodies and antibody fragments thereof that specifically bind to and inhibit TSLP-R are hypothesized to be useful for preventing and treating various diseases in which TSLP and TSLP-R are involved in the pathology of these diseases.

[0075] Generally, the basic antibody structural unit comprises a tetramer, each of which contains two identical pairs of polypeptide chains, each pair having one "light" chain (about 25 kDa) and one "heavy" chain (about 50-70 kDa).

[0076] Human light chains are typically classified as kappa and lambda light chains, and human heavy chains are further typically classified as mu, delta, gamma, alpha, or epsilon, and define the antibody's isotype as IgM, IgD, IgG, IgA, and IgE, respectively.

[0077] The amino-terminal portion of each chain contains a variable region of approximately 100 to 110 amino acids that is primarily responsible for antigen recognition. The variable regions of the light and heavy chains are V L and V H It is abbreviated as.

[0078] The variable region of each chain is followed by one or more constant regions of approximately 100-110 or more amino acids per constant region. The constant regions are identical in all antibodies of the same isotype, or antigen-binding fragments thereof, but differ between different isotypes. The light chains are C L The heavy chain contains one constant region, abbreviated as C. H 1. C H 2. C H 3, etc. The carboxy-terminal portion of the heavy chain may define a constant region primarily responsible for effector function.

[0079] Within light and heavy chains, the variable and constant regions are joined by a "J" region of about 12 or more amino acids, with the heavy chain also including a "D" region of about 10 or more amino acids. See generally, Fundamental Immunology Ch. 7 (Paul, W., ed., 2nd ed. Raven Press, NY (1989)).

[0080] The variable regions of each light / heavy chain pair form an antigen-binding domain or site. Thus, an intact antibody generally has two binding sites. Except for bifunctional or bispecific antibodies, the two binding sites are generally the same.

[0081] As used herein, the term "complementarity determining region," or "hypervariable region," abbreviated as "CDR," refers to the amino acid residues of an antibody, or fragment thereof, that are involved in antigen binding. A CDR may comprise a "hypervariable loop" within a folded antibody, or fragment thereof. Typically, both the heavy and light chain variable domains contain three CDRs, which are located within relatively conserved framework regions (FRs). As used herein, the terms "framework" or "FR" residues refer to those variable domain residues other than the hypervariable region residues defined herein as CDR residues.

[0082] CDRs are usually aligned by framework regions, enabling binding to a specific epitope. Generally, from N-terminus to C-terminus, both light and heavy chain variable domains comprise FR1, CDR1, FR2, CDR2, FR3, CDR3, and FR4. For example, as used herein, the three CDRs in a light chain are abbreviated as CDRL1, CDRL2, and CDRL3, with CDRL1 representing the CDR closest to the N-terminus of the light chain and CDRL3 representing the CDR closest to the C-terminus of the light chain. Similarly, as used herein, the CDRs in a heavy chain containing three CDRs are abbreviated as CDRH1, CDRH2, and CDRH3. The assignment of amino acids to each domain generally follows the definitions in Sequences of Proteins of Immunological Interest, Kabat, et al.; National Institutes of Health, Bethesda, Md.; 5th ed.; NIH Publ. No. 91-3242 (1991); Kabat (1978) Adv. Prot. Chem. 32:1-75; Kabat, et al., (1977) J. Biol. Chem. 252:6609-6616; Chothia, et al., (1987) J Mol. Biol. 196:901-917 or Chothia, et al., (1989) Nature 342:878-883.

[0083] CDRs provide the majority of contact residues for binding of an anti-TSLP-R antibody, or antigen-binding fragment thereof, to an antigen or epitope. The CDRs of interest are derived from the variable heavy and light chain sequences of a donor antibody, or fragment thereof, and may include analogs of naturally occurring CDRs, which also share or retain the same antigen-binding specificity and / or neutralizing capacity as the donor antibody, or fragment thereof, from which they are derived.

[0084] The "Fv region" comprises the variable regions from both the light and heavy chains; i.e., the Fv region comprises a VL and a VH. As used herein, the term "Fv domain" is used interchangeably with "Fv region." Generally, the Fv region further comprises a polypeptide linker between the VH and VL domains, which enables the scFv to form the desired structure for antigen binding. The term "single-chain Fv" or "scFv" antibody refers to an antibody fragment comprising the VH and VL domains of an antibody, or fragment thereof, wherein these domains are present in a single polypeptide chain. For a review of scFvs, see Pluckthun (1994) The Pharmacology of Monoclonal Antibodies, vol. 113, Rosenburg and Moore eds. Springer-Verlag, New York, pp. 269-315. See also International Patent Application Publication No. WO 88 / 01649, and U.S. Patent Nos. 4,946,778 and 5,260,203.

[0085] As used herein, the term "Fab region" or "Fab domain" refers to the region comprising the variable and C regions of one light chain and one heavy chain. H The Fab region is usually used to refer to the region of an antibody or fragment thereof that consists of V L , C L , V H , and C H 1. A "Fab fragment" contains one light chain and one heavy chain C. HThe heavy chain of the Fab region cannot form a disulfide bond with another heavy chain molecule. An "Fab' fragment" is an antibody fragment consisting of one Fab region (V L , C L , V H , and C H 1), and the heavy chains also contain C such that interchain disulfide bonds can form between the two heavy chains of the two Fab' fragments to form an F(ab')2 molecule. H 1 Domain and C H A "F(ab')2 fragment" is a fragment of two Fab' fragments (two light chains and one C domain). H 1 Domain and C H The F(ab')2 fragment contains two heavy chains (containing a portion of the constant region between the two domains) and an interchain disulfide bond is formed between the two heavy chains. Thus, the F(ab')2 fragment is composed of two Fab' fragments held together by disulfide bonds between the two heavy chains.

[0086] As used herein, the term "Fc region" is used interchangeably with "Fc domain," which is defined as the region of an antibody, or fragment thereof, that contains two heavy chains that are bound to each other by two or more disulfide bonds and hydrophobic interactions. An Fc domain typically contains a C domain for each heavy chain. H 2 and C H The two heavy chain fragments are held together by two or more disulfide bonds and by C H The three domains are bound together by hydrophobic interactions.

[0087] A "domain antibody" is an immunologically functional immunoglobulin fragment containing only the variable region of a heavy chain or the variable region of a light chain. In some cases, two or more VH regions are covalently linked with a peptide linker to create a bivalent domain antibody. The two VH regions of a bivalent domain antibody may target the same or different antigens. As used herein, the term "diabody" refers to a small antibody fragment having two antigen-binding domains, where the fragment comprises a heavy-chain variable domain (VH) linked to a light-chain variable domain (VL) in the same polypeptide chain (VH-VL or VL-VH). By using a linker that is too short to allow pairing between the two domains on the same chain, the domains are forced to pair with complementary domains on another chain, generating two antigen-binding sites. Diabodies are described in more detail in, for example, EP 404,097, WO 93 / 11161, and Holliger et al. (1993) Proc. Natl. Acad. Sci. USA 90:6444-6448. For a review of recombinant antibodies, their fragments, and their variants generally, see Holliger and Hudson (2005) Nat. Biotechnol. 23:1126-1136.

[0088] A "bivalent antibody" comprises two antigen-binding sites. In some cases, the two binding sites have the same antigen specificity. In some cases, the two binding sites have different antigen specificities, in which case the antibody is a bispecific antibody. The terms "bispecific antibody" and "multispecific antibody" refer to any antibody that immunospecifically binds to two or more different binding sites with different antigen specificities.

[0089] The term "fully human antibody" refers to an antibody that comprises only human immunoglobulin protein sequences. A fully human antibody may contain mouse glycosylation if made in a mouse, a mouse cell, or a hybridoma derived from a mouse cell. Similarly, a "mouse antibody" refers to an antibody that comprises only mouse immunoglobulin sequences. Alternatively, a fully human antibody may contain rat glycosylation if made in a rat, a rat cell, or a hybridoma derived from a rat cell. Similarly, a "rat antibody" refers to an antibody that comprises only rat immunoglobulin sequences.

[0090] As used herein, a "chimeric antibody" is an antibody having variable domains derived from a first antibody and constant domains derived from a second antibody, wherein the first and second antibodies are from different species. (U.S. Patent No. 4,816,567, and Morrison et al., (1984) Proc. Natl. Acad. Sci. USA 81:6851-6855.) Typically, the variable domains are obtained from an antibody derived from a laboratory animal such as a rodent (the "parent antibody"), and the constant domain sequences are obtained from a human antibody; therefore, the resulting chimeric antibody is less likely to provoke an adverse immune response in a human subject than the parent (e.g., rodent) antibody.

[0091] As used herein, the term "humanized antibody" refers to forms of antibodies that contain sequences derived from both human and non-human (e.g., mouse, rat) antibodies. Generally, a humanized antibody, or fragment thereof, will contain substantially all of at least one, and typically two, variable domains, in which all or substantially all of the hypervariable loops correspond to those of a non-human immunoglobulin and all or substantially all of the framework (FR) regions are those of a human immunoglobulin sequence. A humanized antibody, or fragment thereof, may optionally contain at least a portion of a human immunoglobulin constant region (Fc).

[0092] A "parent antibody" is an antibody obtained by exposing the immune system to an antigen prior to modification of the antibody for its intended use, such as humanizing the antibody for use as a human therapeutic antibody, or fragment thereof.

[0093] The term "monoclonal antibody," as used herein, refers to a population of substantially homogeneous antibodies, i.e., the antibody molecules within the population are identical in amino acid sequence except for possible naturally occurring mutations that may be present in minor amounts. In contrast, conventional (polyclonal) antibody preparations typically contain a large number of different antibodies, or antigen-binding fragments thereof, that have different amino acid sequences within their variable domains, particularly their CDRs, often specific for different epitopes. The modifier "monoclonal" indicates the character of the antibody as obtained from a substantially homogeneous antibody population and is not to be construed as requiring production of the antibody by any particular method. For example, monoclonal antibodies used in accordance with the present disclosure may be made by the hybridoma method first described by Kohler et al. (1975) Nature 256:495, or may be made by recombinant DNA methods (see, e.g., U.S. Pat. No. 4,816,567). Monoclonal antibodies may also be isolated from phage antibody libraries using the techniques described in, for example, Clackson et al. (1991) Nature 352:624-628 and Marks et al. (1991) J. Mol. Biol. 222:581-597. See also, Presta (2005) J. Allergy Clin. Immunol. 116:731.

[0094] As an alternative to preparing monoclonal antibody-secreting hybridomas, monoclonal antibodies against a polypeptide may be identified and isolated by screening a recombinant combinatorial immunoglobulin library (e.g., an antibody phage display library) with a polypeptide described herein, thereby isolating immunoglobulin library members that bind to the polypeptide. Techniques and commercially available kits for generating and screening phage display libraries are well known to those skilled in the art. Furthermore, examples of methods and reagents particularly suited for use in generating and screening antibody display libraries or antigen-binding protein display libraries can be found in the literature. Thus, the epitopes described herein can be used to screen for other antibodies that may be used therapeutically, diagnostically, or as research tools.

[0095] The phrases "antibody that recognizes TSLP-R" and "antibody specific for TSLP-R" are used interchangeably herein with the term "antibody that specifically binds to TSLP-R." This term also includes antibodies specific for CRLF2. In some embodiments, a pharmaceutical composition comprising an anti-TSLP-R antibody is referred to as TRAB-1.

[0096] In some embodiments, an antibody, or antigen-binding fragment thereof, is provided, wherein the antibody, or antigen-binding fragment thereof, is specific for TSLP-R. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is used to detect the presence of an antigen. In some embodiments, the antigen is TSLP-R. In some embodiments, the antibody, or fragment thereof, contains a variable region that specifically binds to TSLP-R. In some embodiments, the antibody, or fragment thereof, specifically binds to one or more antigen-binding sites within TSLP-R. In some embodiments, the antibody, or fragment thereof, binds to amino acids of an epitope of TSLP-R. In some embodiments, the antibody, or fragment thereof, binds to one or more epitopes, wherein the one or more epitopes are antigen-binding sites within TSLP-R. In some embodiments, the present anti-TSLP-R antibody, or antigen-binding fragment thereof, can be used in any device or method for detecting the presence of an antigen.

[0097] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, specifically binds to one or more TSLP-R binding sites, and the KD between the antibody, or fragment thereof, and one or more TSLP-R binding sites is at least twice the KD between the antibody, or fragment thereof, and a non-specific antigen. In some embodiments, the non-specific antigen may include, but is not limited to, BSA, casein, or any other polypeptide that non-specifically binds to an anti-TSLP-R antibody, or antigen-binding fragment thereof. In some embodiments, the antibody, or fragment thereof, binds to its antigen (TSLP-R) with an affinity that is at least 2-fold higher, at least 10-fold higher, at least 20-fold higher, or at least 100-fold higher than the affinity for any other antigen. The degree of specificity required for an anti-TSLP-R antibody, or antigen-binding fragment thereof, may depend on the intended use of the antibody, or fragment thereof, and, in any event, is defined by its suitability for use for the intended purpose.

[0098] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, specifically binds to one or more TSLP-R binding sites, and the KD between the anti-TSLP-R antibody, or antigen-binding fragment thereof, and the one or more TSLP-R binding sites is at least 10 -6 , 10 -7 , 10 -8 , 10 -9 , 10 -10 , 10 -11 , 10 -12 , or 10 -13 In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is highly specific for one or more TSLP-R binding sites and has a KD of at least about 10 -9 In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is highly specific for one or more TSLP-R binding sites and has a KD of at least about 10 -12 It's M.

[0099] In some embodiments, the antigen is a TSLP-R protein expressed on the surface of a cell. In some embodiments, the cell is an intact cell. In some embodiments, the cell is not an intact cell. An intact cell is a cell that has not been lysed or disrupted using a detergent or other reagent. A cell that has been treated with a detergent or other reagent that disrupts or creates holes in the cell membrane is not an intact cell. For example, provided herein is a method for producing an antibody, or a fragment thereof, that binds to a TSLP-R protein, the method comprising culturing cells containing a nucleic acid molecule encoding a TSLP-R antibody or a fragment thereof.

[0100] In some embodiments, the anti-TSLP-R antibody comprises at least two light chains and at least two heavy chains. In some embodiments, the anti-TSLP-R antibody comprises a tetramer. In some embodiments, the tetramer comprises two light chains and two heavy chains. In some embodiments, the anti-TSLP-R antibody comprises one or more tetramers. In some embodiments, the anti-TSLP-R antibody comprises two, five, or more tetramers. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is an IgM, IgD, IgG, IgA, or IgE isotype, or any combination thereof.

[0101] In some embodiments, the anti-TSLP-R antibody fragment comprises a monomer or oligomer. In some embodiments, the oligomer comprises two, three, four, five, or more monomers. In some embodiments, the monomer comprises an intact light chain or a portion thereof, or an intact heavy chain or a portion thereof. In some embodiments, the oligomer comprises two or more monomers, and the two or more monomers comprise one or more intact light chains, light chain portions, intact heavy chains, heavy chain portions, or combinations thereof.

[0102] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more chains, including a kappa light chain, a lambda light chain, a mu heavy chain, a delta heavy chain, a gamma heavy chain, an alpha heavy chain, an epsilon heavy chain, or a combination thereof. In some embodiments, an anti-TSLP-R antibody fragment comprises an intact chain, a chain portion, or a combination of an intact chain and a chain portion. In some embodiments, one or more intact heavy chains, or portions thereof, comprise one, two, three, or four constant regions. In some embodiments, the constant region comprises one, two, three, or four constant regions. H 1. C H 2. C H 3 or C H 4 constant regions, or any combination thereof.

[0103] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more antibody regions, wherein the one or more antibody regions are L , V H , C L , C H 1. C H 2. C H 3 or C H 4, or any combination thereof. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more linkers, wherein the N-terminus of the linker is V L , V H , C L , C H 1. C H 2. C H 3, or C H 4 is covalently linked to the C-terminus of the linker, V L , V H , C L , C H 1. C H 2. C H 3, or C H 4. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, further comprises a "J" region. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, further comprises a "D" region.

[0104] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more of the amino acid sequences as provided herein. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises an antigen-binding domain comprising one or more of the amino acid sequences as provided herein. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, or antigen-binding fragment thereof, has at least 50, 60, 70, 80, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99% homology or identity to a sequence described herein.

[0105] In some embodiments, the antibody comprises one or more peptides having a sequence as listed in Table 1, or a variant thereof. [Table 1]

[0106] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more heavy chains (HC). In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more heavy chains having the amino acid sequence of SEQ ID NO: 1. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises two heavy chains having the amino acid sequence of SEQ ID NO: 1. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain encoded by the nucleotide sequence of SEQ ID NO: 2: TIFF2025538151000003.tif113128

[0107] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain having the amino acid sequence of SEQ ID NO:1, which is encoded by the nucleotide sequence of SEQ ID NO:2.

[0108] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more light chains (LC). In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more light chains having the amino acid sequence of SEQ ID NO: 3. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises two light chains having the amino acid sequence of SEQ ID NO: 3.

[0109] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a light chain encoded by the nucleotide sequence of SEQ ID NO:4: TIFF2025538151000004.tif58128

[0110] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more heavy chains having the amino acid sequence of SEQ ID NO:1, encoded by the nucleotide sequence of SEQ ID NO:2, and one or more light chains having the amino acid sequence of SEQ ID NO:3, encoded by the nucleotide sequence of SEQ ID NO:4. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises two heavy chains having the amino acid sequence of SEQ ID NO:1, encoded by the nucleotide sequence of SEQ ID NO:2, and two light chains having the amino acid sequence of SEQ ID NO:3, encoded by the nucleotide sequence of SEQ ID NO:4. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a light chain having the amino acid sequence of SEQ ID NO:3, encoded by the nucleotide sequence of SEQ ID NO:4.

[0111] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 1. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a light chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:3. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:1, and a light chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:3.

[0112] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more variable heavy chain (VH) polypeptides. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises one or more variable light chain (VL) polypeptides. In some embodiments, the antibody heavy chain sequence comprises the variable heavy chain of an antibody, and the antibody light chain sequence comprises the variable light chain of an antibody. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable heavy chain polypeptide VH and a variable light chain polypeptide VL having the sequences set forth in Table 2. [Table 2]

[0113] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable heavy chain polypeptide having the amino acid sequence of SEQ ID NO:5.

[0114] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable light chain polypeptide having the amino acid sequence of SEQ ID NO:6.

[0115] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable heavy chain polypeptide having the amino acid sequence of SEQ ID NO:5 and a variable light chain polypeptide having the amino acid sequence of SEQ ID NO:6.

[0116] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable heavy chain polypeptide having an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 5. In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable light chain polypeptide having an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:6. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable heavy chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:5, and a variable light chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:6.

[0117] In some embodiments, antibodies, or antigen-binding fragments thereof, are provided, wherein the antibodies or antibody fragments comprise a CDR polypeptide selected from Table 3. As used herein, the terms LCDR1, LCDR2, and LCDR3 refer to CDR1, CDR2, and CDR3 of the light chain. As used herein, the terms HCDR1, HCDR2, and HCDR3 refer to CDR1, CDR2, and CDR3 of the heavy chain. In some embodiments, an anti-TSLP-R antibody, or anti-TSLP-R antibody fragment thereof, contains one or more CDR regions. In some embodiments, an anti-TSLP-R antibody, or anti-TSLP-R antibody fragment thereof, contains one or more CDR regions having a sequence selected from Table 3. [Table 3]

[0118] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain HCDR1, HCDR2, and HCDR3 comprising the amino acid sequences of SEQ ID NOs: 7, 8, and 9, respectively. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, comprises a heavy chain comprising an HCDR1 amino acid sequence of SEQ ID NO: 7, an HCDR2 amino acid sequence of SEQ ID NO: 8, and an HCDR3 amino acid sequence of SEQ ID NO: 9. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, comprises an HCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 7, at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 8. and a heavy chain comprising an HCDR2 amino acid sequence that is 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% identical to SEQ ID NO:9, and an HCDR3 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:9.

[0119] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain polypeptide having an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 1, provided that the heavy chain polypeptide comprises an HCDR1 amino acid sequence of SEQ ID NO: 7, an HCDR2 amino acid sequence of SEQ ID NO: 8, and an HCDR3 amino acid sequence of SEQ ID NO: 9.

[0120] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable heavy chain HCDR1, HCDR2, and HCDR3 comprising the amino acid sequences of SEQ ID NOs: 7, 8, and 9, respectively. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, comprises a variable heavy chain comprising the HCDR1 amino acid sequence of SEQ ID NO: 7, the HCDR2 amino acid sequence of SEQ ID NO: 8, and the HCDR3 amino acid sequence of SEQ ID NO: 9. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, comprises an HCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 7, at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 8 .... 9, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% identical to SEQ ID NO:9, and a variable heavy chain comprising an HCDR2 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:9.

[0121] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a light chain LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of SEQ ID NOs: 10, 11, and 12, respectively. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, comprises a light chain comprising the LCDR1 amino acid sequence of SEQ ID NO: 10, the LCDR2 amino acid sequence of SEQ ID NO: 11, and the LCDR3 amino acid sequence of SEQ ID NO: 12. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, comprises a LCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 10, at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 1 ... and a light chain comprising an LCDR2 amino acid sequence that is 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% identical to SEQ ID NO:12, and an LCDR3 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:12.

[0122] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a light chain polypeptide having an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:3, provided that the light chain polypeptide comprises an LCDR1 amino acid sequence of SEQ ID NO:10, an LCDR2 amino acid sequence of SEQ ID NO:11, and an LCDR3 amino acid sequence of SEQ ID NO:12.

[0123] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises variable light chains LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of SEQ ID NOs: 10, 11, and 12, respectively. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, comprises a variable light chain comprising the LCDR1 amino acid sequence of SEQ ID NO: 10, the LCDR2 amino acid sequence of SEQ ID NO: 11, and the LCDR3 amino acid sequence of SEQ ID NO: 12. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, comprises an LCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 10, at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 1 .... and a variable light chain comprising an LCDR2 amino acid sequence that is 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% identical to SEQ ID NO:12, and an LCDR3 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:12.

[0124] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises heavy chain HCDR1, HCDR2, and HCDR3 comprising the amino acid sequences of SEQ ID NOs: 7, 8, and 9, respectively, and light chain LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of SEQ ID NOs: 10, 11, and 12, respectively. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, comprises a heavy chain comprising the HCDR1 amino acid sequence of SEQ ID NO: 7, the HCDR2 amino acid sequence of SEQ ID NO: 8, and the HCDR3 amino acid sequence of SEQ ID NO: 9, and a light chain comprising the LCDR1 amino acid sequence of SEQ ID NO: 10, the LCDR2 amino acid sequence of SEQ ID NO: 11, and the LCDR3 amino acid sequence of SEQ ID NO: 12.In some embodiments, the anti-TSLP-R antibody, or fragment thereof, has an HCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:7, at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:8. 9, 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% identical to SEQ ID NO:9, and an HCDR2 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:9. and LCDR1 amino acid sequences that are at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 10, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91%, at least 92%, at least 98%, or at least 99% identical to SEQ ID NO: 11. and a light chain comprising an LCDR2 amino acid sequence that is at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% identical to SEQ ID NO: 12, and an LCDR3 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 12.

[0125] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a heavy chain polypeptide having an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 1, with the proviso that the heavy chain polypeptide comprises an HCDR1 amino acid sequence of SEQ ID NO: 7, an HCDR2 amino acid sequence of SEQ ID NO: 8, and an HCDR3 amino acid sequence of SEQ ID NO: 9. and a light chain polypeptide having an amino acid sequence at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:3, provided that the light chain polypeptide comprises an LCDR1 amino acid sequence of SEQ ID NO:10, an LCDR2 amino acid sequence of SEQ ID NO:11, and an LCDR3 amino acid sequence of SEQ ID NO:12.

[0126] In some embodiments, an anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises variable heavy chain HCDR1, HCDR2, and HCDR3 comprising the amino acid sequences of SEQ ID NOs: 7, 8, and 9, respectively, and variable light chain LCDR1, LCDR2, and LCDR3 comprising the amino acid sequences of SEQ ID NOs: 10, 11, and 12, respectively. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, comprises a variable heavy chain comprising the HCDR1 amino acid sequence of SEQ ID NO: 7, the HCDR2 amino acid sequence of SEQ ID NO: 8, and the HCDR3 amino acid sequence of SEQ ID NO: 9, and a variable light chain comprising the LCDR1 amino acid sequence of SEQ ID NO: 10, the LCDR2 amino acid sequence of SEQ ID NO: 11, and the LCDR3 amino acid sequence of SEQ ID NO: 12.In some embodiments, the anti-TSLP-R antibody, or fragment thereof, has an HCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:7, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:8, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:9, 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% identical to SEQ ID NO:10, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:11, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:12, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:13, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:14, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 91% identical to SEQ ID NO:15, at least 70%, at least 7 , 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% identical to SEQ ID NO:9, and an HCDR2 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO:9. and a LCDR1 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 10, at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 11. and a variable light chain comprising an LCDR2 amino acid sequence that is at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% identical to SEQ ID NO: 12, and an LCDR3 amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, 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% identical to SEQ ID NO: 12.

[0127] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, has conservative substitutions compared to the sequences described herein. Exemplary conservative substitutions are shown in Table 4 and are encompassed within the scope of the disclosed subject matter. In some embodiments, conservative substitutions may be made within framework regions or within the antigen-binding site, so long as they do not adversely affect the properties of the antibody or fragment thereof. In some embodiments, substitutions may be made to improve the properties of the antibody or fragment thereof, such as stability or affinity. In some embodiments, conservative substitutions will generate molecules with similar functional and chemical properties to the molecule in which such modifications are made. Exemplary amino acid substitutions are shown in the table below. [Table 4]

[0128] In some embodiments, variants of the proteins and peptides provided herein are provided. In some embodiments, the variants comprise substitutions, deletions, or insertions. In some embodiments, the variants comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 (e.g., 1-10) substitutions. In some embodiments, the substitutions can be conservative. In some embodiments, the substitutions are non-conservative. In some embodiments, the variants comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 (e.g., 1-10) deletions. In some embodiments, the variants comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 (e.g., 1-10) insertions. In some embodiments, the substitutions, deletions, or insertions are present in a CDR provided herein. In some embodiments, the substitutions, deletions, or insertions are not present within a CDR provided herein.

[0129] In some embodiments, "derivatives" of antibodies are provided. The term "derivative" includes proteins encoded by truncated or modified genes to obtain molecular species functionally similar to immunoglobulins or immunoglobulin fragments. In some embodiments, modifications may include, but are not limited to, the addition of genetic sequences encoding cytotoxic proteins, such as plant and bacterial toxins. In some embodiments, modifications may also include reporter proteins, such as fluorescent or chemiluminescent tags. In some embodiments, fragments and derivatives may be produced by any method.

[0130] In some embodiments, anti-TSLP-R antibodies, or antigen-binding fragments thereof, can include, but are not limited to, monoclonal, polyclonal, bispecific, humanized, fully human, chimeric, or single-domain antibodies, or fragments thereof, or any combination thereof.

[0131] In some embodiments, anti-TSLP-R antibody fragments can include, but are not limited to, Fab, Fab', F(ab')2, Fv fragments, diabodies, linear antibodies, single-chain antibodies, sc-Fv, nanobodies, or multispecific antibody fragments, or any combination thereof.

[0132] In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is isolated. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, 99.5%, 99.9%, or 100% (w / w) pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 70%-80%, 75%-80%, 75%-85%, 80%-85%, 80%-90%, 85%-90%, 85%-95%, or 90%-95% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 70% to at least 80% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 75% to at least 80% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 75% to at least 85% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 80% to at least 85% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 80% to at least 90% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 85% to at least 90% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 85% to at least 95% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 90% to at least 95% pure. In some embodiments, the anti-TSLP-R antibody, or fragment thereof, is at least 95% to at least 99% pure.

[0133] In some embodiments, an anti-TSLP-R antibody, or fragment thereof, specifically binds to one or more TSLP-R proteins, including, but not limited to, one or more TSLP-R proteins from a primate, such as a human or monkey, mouse, rat, other rodent, rabbit, dog, cat, pig, cow, sheep, or horse, or any combination thereof. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, specifically binds to the human TSLP-R. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, specifically binds to the mouse TSLP-R. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, specifically binds to one TSLP-R protein from a human and at least one additional TSLP-R protein from another species, including, but not limited to, a primate, such as a monkey, mouse, rat, other rodent, rabbit, dog, cat, pig, cow, sheep, or horse, or any combination thereof. In some embodiments, an anti-TSLP-R antibody, or fragment thereof, specifically binds to one TSLP-R protein from mouse and at least one additional TSLP-R protein from another species, which may include, but is not limited to, a primate such as a human or monkey, a rat, another rodent, a rabbit, a dog, a cat, a pig, a cow, a sheep, or a horse, or any combination thereof.

[0134] In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is a MAb that binds to TSLP-R. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is human IgG. In some embodiments, the anti-TSLP-R antibody, or antigen-binding fragment thereof, is a variant of human IgG. A "human IgG variant" refers to an antibody that has been modified to be a human IgG or fragment thereof when the starting antibody is not a human IgG antibody or fragment thereof. In some embodiments, the sequence of the antibody, or antigen-binding fragment thereof, can be modified to obtain a human IgG antibody or antigen-binding fragment thereof. In some embodiments, conversion of the sequences provided herein can be modified to obtain other types of antibodies or antigen-binding fragments thereof. In some embodiments, the CDRs can also be linked to other antibodies, or antigen-binding fragments thereof, that bind TSLP-R. In some embodiments, the CDRs can also be linked to other proteins or molecules to generate antibodies, or fragments thereof, that bind TSLP-R.

[0135] In some embodiments, the variable regions of the anti-TSLP-R antibodies, or antigen-binding fragments thereof, as described herein, can be combined with any type of constant region, including human or mouse constant regions. In some embodiments, the constant region contains mutations at amino acid residue positions relative to the wild-type human IgG constant domain, numbered according to the EU numbering index of Kabat. In some embodiments, the mutations increase the half-life of the anti-TSLP-R antibodies, or antigen-binding fragments thereof, compared to the half-life of an IgG having a wild-type human IgG constant domain.

[0136] In some embodiments, the antibody, or fragment thereof, comprises an Fc region. In some embodiments, the Fc region comprises a mutation that, when linked to the Fc region, extends the half-life of the anti-TSLP-R antibody, or antigen-binding fragment thereof. In some embodiments, the Fc domain comprises mutations such as those described in US2007041972A1, EP2235059B1, U.S. Patent No. 7,670,600, U.S. Patent No. 8,394,925, and Mueller et al., Mol Immunol 1997 Apr;34(6):441-52 (each of which is incorporated by reference in its entirety). Numbering referred to herein refers to the Kabat numbering system for the Fc region.

[0137] As described herein, it is also contemplated that the antibodies, or fragments thereof, of the present disclosure may include conservative or non-conservative amino acid substitutions, which may also be referred to as "conservative variants" or "function-conservative variants" of an antibody or fragment thereof that do not substantially alter its biological activity. In some embodiments, a variant antibody, or fragment thereof, or antigen-binding fragment of the antibody provided herein retains at least 10% of its TSLP-R binding activity (compared to the modified parent antibody or fragment thereof) when the activity is expressed on a molar basis. In some embodiments, a variant antibody, or fragment thereof, provided herein retains at least 20%, 50%, 70%, 80%, 90%, 95%, or 100% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof.

[0138] In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 20% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof. In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 50% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof. In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 70% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof. In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 80% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof. In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 90% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof. In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 95% or more of the TSLP-R binding affinity of the parent antibody or fragment thereof. In some embodiments, the variant antibodies, or fragments thereof, provided herein retain at least 100% of the TSLP-R binding affinity of the parent antibody or fragment thereof.

[0139] The antibodies provided herein may be conjugated to a chemical moiety. The chemical moiety may be, among others, a polymer, a radionuclide, or a cytotoxic agent. In some embodiments, this may be referred to as an antibody-drug conjugate. In some embodiments, the chemical moiety is a polymer that increases the half-life of the antibody molecule in the subject's body. Suitable polymers include, but are not limited to, polyethylene glycol (PEG) (e.g., PEG having a molecular weight of 2 kDa, 5 kDa, 10 kDa, 12 kDa, 20 kDa, 30 kDa, or 40 kDa), dextran, and monomethoxypolyethylene glycol (mPEG). Lee, et al., (1999) (Bioconj. Chem. 10:973-981) discloses PEG-conjugated single-chain antibodies. Wen, et al. (2001) (Bioconj. Chem. 12:545-553) discloses conjugation of antibodies with PEG linked to a radiometal chelator (diethylenetriaminepentaacetic acid (DTPA)). Examples of chemical moieties include, but are not limited to, antimitotic agents such as calicheamicins (e.g., ozogamicin), monomethyl auristatin E, mertansine, and the like. Other examples include, but are not limited to, biologically active antimicrotubule agents, alkylating agents, and DNA minor groove binders. Further examples are provided herein and below. Chemical moieties can be linked to antibodies via linking groups (maleimides), cleavable linkers such as cathepsin-cleavable linkers (valine-citrulline), and, in some embodiments, one or more spacers (e.g., para-aminobenzyl carbamates). Without being bound to any particular theory, when the antibody conjugate binds to TSLP-R, the antibody conjugate may be internalized and the chemical moiety may kill the cell or otherwise inhibit its proliferation.

[0140] The antibodies and antigen-binding fragments of the disclosure may also be labeled, e.g., 99 Tc, 90 Y, 111 In, 32 P, 14 C. 125 I, 3 H, 131I, 11 C. 15 O. 13 N, 18 F, 35 S, 51 Cr, 57 To, 226 Ra, 60 Co, 59 Fe, 57 Se, 152 EU, 67 CU, 217 Ci, 211 At, 212 Pb, 47 Sc, 109 Pd, 234 Th, and 40 K. 157 Gd, 55 Mn, 52 Tr, and 56 It may be compounded with Fe or the like.

[0141] Antibodies, and antibody fragments thereof, may also be conjugated to fluorescent or chemiluminescent labels, including fluorophores such as rare earth chelates, fluorescein and its derivatives, rhodamine and its derivatives, isothiocyanates, phycoerythrin, phycocyanin, allophycocyanin, o-phthaladehyde, fluorescamine, 152Eu, dansyl, umbelliferone, luciferin, luminal labels, isoluminal labels, aromatic acridinium ester labels, imidazole labels, acridinium salt labels, oxalate ester labels, aequorin labels, 2,3-dihydrophthalazinedione, biotin / avidin, spin labels, and stable free radicals.

[0142] Antibody molecules may also be conjugated to cytotoxic agents such as diphtheria toxin, Pseudomonas aeruginosa exotoxin A chain, ricin A chain, abrin A chain, modeccin A chain, alpha-sarcin, Aleurites fordii proteins and compounds (e.g., fatty acids), dianthin proteins, Phytolacca americana proteins PAPI, PAPII, and PAP-S, momordica charantia inhibitor, curcin, crotin, saponaria officinalis inhibitor, mitogenin, restrictocin, phenomycin, and enomycin.

[0143] Any method known in the art for conjugating antibody molecules of the present disclosure to various moieties may be used, including those described by Hunter, et al., (1962) Nature 144:945, David, et al., (1974) Biochemistry 13:1014, Pain, et al., (1981) J. Immunol. Meth. 40:219, and Nygren, J., (1982) Histochem. and Cytochem. 30:407. Methods for conjugating antibodies are conventional and well known in the art.

[0144] Pharmaceutical Composition The term "composition," as used herein, means a product resulting from the mixing or combining of two or more elements or components.

[0145] The term "carrier," as used herein, encompasses carriers, excipients, and diluents, and means a material, composition, or vehicle, such as a liquid or solid filler, diluent, excipient, solvent, or encapsulating material, that participates in the carrying or transport of a pharmaceutical, cosmetic, or other agent across a tissue layer.

[0146] The phrase "pharmaceutically acceptable" is used herein to refer to subject agents / compounds, salts, compositions, pharmaceutical dosage forms, etc. that are suitable, within the scope of sound medical judgment, for use in contact with the tissues of humans and / or other mammals without undue toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio. In some embodiments, pharmaceutically acceptable means approved by a federal or state regulatory agency or listed in the United States Pharmacopeia or other generally recognized pharmacopoeias for use in animals (e.g., mammals), and more particularly in humans.

[0147] The term "stable" as used herein means having stability to, for example, heat, light, temperature, and / or humidity.

[0148] The term "excipient" refers to a pharmacologically inactive substance that is formulated with an antibody, or antigen-binding fragment thereof, as described herein.

[0149] In some embodiments, the pharmaceutical composition comprises: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) an excipient at a concentration of about 1 mmol / L to about 600 mmol / L; and (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v).

[0150] In some embodiments, pharmaceutical compositions are provided, comprising an anti-TSLP-R antibody, or one or more antigen-binding fragments thereof. In some embodiments, pharmaceutical compositions are provided, comprising an anti-TSLP-R antibody, or one or more antigen-binding fragments thereof, as disclosed herein.

[0151] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or a fragment thereof, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9, or a variant of any of the foregoing. a heavy chain variable region comprising: (ii) a light chain CDR1, CDR2, and CDR3 sequence, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12, or a variant of any of the foregoing. a light chain variable region comprising Includes:

[0152] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or a fragment thereof, wherein the anti-TSLP-R antibody, or an antigen-binding fragment thereof, comprises a variable 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:5.

[0153] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable 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:5, provided that the heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO:7, SEQ ID NO:8, and SEQ ID NO:9.

[0154] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or fragment thereof, comprises a variable 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:6.

[0155] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable 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:6, provided that the light chain polypeptide comprises the amino acid sequence of SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12.

[0156] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or fragment thereof, comprises (i) a variable heavy chain polypeptide having a sequence at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having a sequence at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO:6.

[0157] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, that comprises (i) a variable heavy chain polypeptide having a sequence at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO:5, provided that the heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO:7, SEQ ID NO:8, and SEQ ID NO:9, and (ii) a variable light chain polypeptide having a sequence at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% identical to the sequence of SEQ ID NO:6, provided that the light chain polypeptide comprises the amino acid sequence of SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12.

[0158] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or fragment thereof, comprises a variable heavy chain polypeptide having the sequence of SEQ ID NO:5.

[0159] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or fragment thereof, comprises a variable light chain polypeptide having the sequence of SEQ ID NO:6.

[0160] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the anti-TSLP-R antibody, or fragment thereof, comprises (i) a variable heavy chain polypeptide having the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having the sequence of SEQ ID NO:6.

[0161] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 1000 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 900 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 800 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 700 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 600 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 500 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 400 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 1 mg / mL to about 300 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 50 mg / mL to about 250 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 100 mg / mL to about 200 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 150 mg / mL to about 200 mg / mL.

[0162] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 25 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 50 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 100 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 125 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 150 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 155 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 160 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 165 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 170 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 175 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 180 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 185 mg / mL.In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 190 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 195 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 200 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 205 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 210 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 215 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 220 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 225 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 230 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 235 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 240 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 245 mg / mL.In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 250 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 255 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 260 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 265 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 270 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 275 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 280 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 285 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 290 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 300 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 325 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 350 mg / mL.In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 375 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 400 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 425 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 450 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 475 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 500 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 525 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 550 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 575 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 600 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 700 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a concentration of about 800 mg / mL.In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 900 mg / mL. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 1000 mg / mL.

[0163] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 200 mg / mL or less.

[0164] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a dose of about 0.01 mg / kg to about 15 mg / kg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a dose of about 0.02 mg / kg to about 15 mg / kg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a dose of about 0.03 mg / kg to about 10 mg / kg.

[0165] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a dose of 0.01 mg / kg to 15 mg / kg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a dose of 0.02 mg / kg to 15 mg / kg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment is present at a dose of 0.03 mg / kg to 10 mg / kg.

[0166] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present in an amount of about 10 mg to about 700 mg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present in an amount of about 25 mg to about 600 mg.

[0167] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present in an amount of 10 mg to 700 mg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present in an amount of 25 mg to 600 mg.

[0168] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is at a concentration of about 0.01 mg / kg, about 0.02 mg / kg, about 0.03 mg / kg, about 0.04 mg / kg, about 0.05 mg / kg, about 0.06 mg / kg, about 0.07 mg / kg, about 0.08 mg / kg, about 0.09 mg / kg, about 0.1 mg / kg, about 0.2 mg / kg, about 0.3 mg / kg, about 0.4 mg / kg, about 0.5 mg / kg, about 0.6 mg / kg, about 0.7 mg / kg, about 0.8 mg / kg, or about 0.9 mg / kg , about 1.0mg / kg, about 1.1mg / kg, about 1.2mg / kg, about 1.3mg / kg, about 1.4mg / kg, about 1.5mg / kg, about 1.6mg / kg, about 1.7mg / kg, about 1.8mg / kg, about 1.9mg / kg, about 2.0mg / kg, about 2.1mg / kg, about 2. 2mg / kg, about 2.3mg / kg, about 2.4mg / kg, about 2.5mg / kg, about 2.6mg / kg, about 2.7mg / kg, about 2.8mg / kg, about 2.9mg / kg, about 3.0mg / kg, about 3.1mg / kg, about 3.2mg / kg, about 3.3mg / kg, about 3.4mg / kg kg, about 3.5 mg / kg, about 3.6 mg / kg, about 3.7 mg / kg, about 3.8 mg / kg, about 3.9 mg / kg, about 4.0 mg / kg, about 4.1 mg / kg, about 4.2 mg / kg, about 4.3 mg / kg, about 4.4 mg / kg, about 4.5 mg / kg, about 4.6 mg / kg, about 4.7mg / kg, approximately 4.8mg / kg, approximately 4.9mg / kg, approximately 5.0mg / kg, approximately 5.1mg / kg, approximately 5.2mg / kg, approximately 5.3mg / kg, approximately 5.4mg / kg, approximately 5.5mg / kg, approximately 5.6mg / kg, approximately 5.7mg / kg, approximately 5.8mg / kg, approximately 5.9m g / kg, approximately 6.0 mg / kg, approximately 6.1 mg / kg, approximately 6.2 mg / kg, approximately 6.3 mg / kg, approximately 6.4 mg / kg, approximately 6.5 mg / kg, approximately 6.6 mg / kg, approximately 6.7 mg / kg, approximately 6.8 mg / kg, approximately 6.9 mg / kg, approximately 7.0 mg / kg, approximately 7.1 mg / kg , about 7.2 mg / kg, about 7.3 mg / kg, about 7.4 mg / kg, about 7.5 mg / kg, about 7.6 mg / kg, about 7.7 mg / kg, about 7.8 mg / kg, about 7.9 mg / kg, about 8.0 mg / kg, about 8.1 mg / kg, about 8.2 mg / kg, about 8.3 mg / kg, about 8.4mg / kg, about 8.5mg / kg, about 8.6mg / kg, about 8.7mg / kg, about 8.8mg / kg, about 8.9mg / kg, about 9.0mg / kg, about 9.1mg / kg, about 9.2mg / kg, about 9.3mg / kg, about 9.4mg / kg, approximately 9.5mg / kg, approximately 9.6mg / kg, approximately 9.7mg / kg, approximately 9.8mg / kg, approximately 9.9mg / kg, approximately 10.0mg / kg, approximately 10.1mg / kg, approximately 10.2mg / kg, approximately 10.3mg / kg, approximately 10.4m g / kg, about 10.5 mg / kg, about 10.6 mg / kg, about 10.7 mg / kg, about 10.8 mg / kg, about 10.9 mg / kg, about 11.0 mg / kg, about 11.1 mg / kg, about 11.2 mg / kg, about 11.3 mg / kg, about 11.4 mg / kg, about 11.5 mg / kg, about 11.6 mg / kg, about 11.7 mg / kg, about 11.8 mg / kg, about 11.9 mg / kg, about 12.0 mg / kg, about 12.1 mg / kg, about 12.2 mg / kg, about 12. 3mg / kg, about 12.4mg / kg, about 12.5mg / kg, about 12.6mg / kg, about 12.7mg / kg, about 12.8mg / kg, about 12.9mg / kg, about 13.0mg / kg, about 13.1mg / kg, about 13.2mg / kg, about 13.3mg / kg, about 13.4mg / kg, about 13.5mg / kg, about 13.6mg / kg, about 13.7mg / kg, about 13.8mg / kg, about 13.9mg / kg, about 14.0mg / kg, about 14.1mg / kg, about 1 The compound is present in a dose of about 4.2 mg / kg, about 14.3 mg / kg, about 14.4 mg / kg, about 14.5 mg / kg, about 14.6 mg / kg, about 14.7 mg / kg, about 14.8 mg / kg, about 14.9 mg / kg, about 15.0 mg / kg, about 15.1 mg / kg, about 15.2 mg / kg, about 15.3 mg / kg, about 15.4 mg / kg, about 15.5 mg / kg, about 15.6 mg / kg, about 15.7 mg / kg, about 15.8 mg / kg, or about 15.9 mg / kg.

[0169] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is at a concentration of 0.01 mg / kg, 0.02 mg / kg, 0.03 mg / kg, 0.04 mg / kg, 0.05 mg / kg, 0.06 mg / kg, 0.07 mg / kg, 0.08 mg / kg, 0.09 mg / kg, 0.1 mg / kg, 0.2 mg / kg, 0.3 mg / kg, 0.4 mg / kg, 0.5 mg / kg, 0.6 mg / kg, 0.7 mg / kg, 0.8 mg / kg, 0.9 mg / kg, 1.0 mg / kg, 1.1 mg / kg, 1.2mg / kg, 1.3mg / kg, 1.4mg / kg, 1.5mg / kg, 1.6mg / kg, 1.7mg / kg, 1.8mg / kg, 1.9mg / kg, 2.0mg / kg, 2.1mg / kg, 2.2mg / kg, 2.3mg / kg, 2.4mg / kg, 2.5mg / kg , 2.6mg / kg, 2.7mg / kg, 2.8mg / kg, 2.9mg / kg, 3.0mg / kg, 3.1mg / kg, 3.2mg / kg, 3.3mg / kg, 3.4mg / kg, 3.5mg / kg, 3.6mg / kg, 3.7mg / kg, 3.8mg / kg, 3.9mg / k g, 4.0mg / kg, 4.1mg / kg, 4.2mg / kg, 4.3mg / kg, 4.4mg / kg, 4.5mg / kg, 4.6mg / kg, 4.7mg / kg, 4.8mg / kg, 4.9mg / kg, 5.0mg / kg, 5.1mg / kg, 5.2mg / kg, 5.3mg / kg, 5.4mg / kg, 5.5mg / kg, 5.6mg / kg, 5.7mg / kg, 5.8mg / kg, 5.9mg / kg, 6.0mg / kg, 6.1mg / kg, 6.2mg / kg, 6.3mg / kg, 6.4mg / kg, 6.5mg / kg, 6.6mg / kg, 6.7m g / kg, 6.8mg / kg, 6.9mg / kg, 7.0mg / kg, 7.1mg / kg, 7.2mg / kg, 7.3mg / kg, 7.4mg / kg, 7.5mg / kg, 7.6mg / kg, 7.7mg / kg, 7.8mg / kg, 7.9mg / kg, 8.0mg / kg, 8.1 mg / kg, 8.2mg / kg, 8.3mg / kg, 8.4mg / kg, 8.5mg / kg, 8.6mg / kg, 8.7mg / kg, 8.8mg / kg, 8.9mg / kg, 9.0mg / kg, 9.1mg / kg, 9.2mg / kg, 9.3mg / kg, 9.4mg / kg, 9.5mg / kg, 9.6mg / kg, 9.7mg / kg, 9.8mg / kg, 9.9mg / kg, 10.0mg / kg, 10.1mg / kg, 10.2mg / kg, 10.3mg / k g, 10.4mg / kg, 10.5mg / kg, 10.6mg / kg, 10.7mg / kg, 10.8mg / kg, 10.9mg / kg, 11.0mg / kg, 11.1mg / kg, 11.2mg / kg, 11.3mg / kg, 11.4mg / kg, 11.5mg / kg, 11.6mg / kg, 11.7mg / kg, 11.8mg / kg, 11.9mg / kg, 12 .0mg / kg, 12.1mg / kg, 12.2mg / kg, 12.3mg / kg, 12.4mg / kg, 12.5mg / kg, 12.6mg / kg, 12.7mg / kg, 12.8 mg / kg, 12.9mg / kg, 13.0mg / kg, 13.1mg / kg, 13.2mg / kg, 13.3mg / kg, 13.4mg / kg, 13.5mg / kg, 13.6m g / kg, 13.7mg / kg, 13.8mg / kg, 13.9mg / kg, 14.0mg / kg, 14.1mg / kg, 14.2mg / kg, 14.3mg / kg, 14.4mg / It is present in doses of 14.5mg / kg, 14.6mg / kg, 14.7mg / kg, 14.8mg / kg, 14.9mg / kg, 15.0mg / kg, 15.1mg / kg, 15.2mg / kg, 15.3mg / kg, 15.4mg / kg, 15.5mg / kg, 15.6mg / kg, 15.7mg / kg, 15.8mg / kg, or 15.9mg / kg.

[0170] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the antibody, or antigen-binding fragment thereof, is at about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, 110 mg, about 115 mg, about 120 mg, about 125 mg, about 130 mg, about 135 mg, about 140 mg, about 145 mg, about 150 mg, about 155 mg, about 160mg, 165mg, 170mg, 175mg, 180mg, 185mg, 190mg, 195mg, 200mg, 210mg, 215mg, 220mg, 225mg, 230mg, 235mg, 240mg, 245mg, 250m g, approx. 255 mg, approx. 260 mg, approx. 265 mg, approx. 270 mg, approx. 275 mg, approx. 280 mg, approx. 285 mg, approx. 290 mg, approx. 45mg, approx. 350mg, approx. 355mg, approx. 360mg, approx. 365mg, approx. 370mg, approx. 375mg, approx. 380mg, approx. 385mg, approx. 390mg, approx. g, approx. 440 mg, approx. 445 mg, approx. 450 mg, approx. 455 mg, approx. 460 mg, approx. 465 mg, approx. 470 mg, approx. 475 mg, approx. The compound is present in an amount of about 30 mg, about 535 mg, about 540 mg, about 545 mg, about 550 mg, about 555 mg, about 560 mg, about 565 mg, about 570 mg, about 575 mg, about 580 mg, about 585 mg, about 590 mg, about 595 mg, about 600 mg, about 610 mg, about 615 mg, about 620 mg, about 625 mg, about 630 mg, about 635 mg, about 640 mg, about 645 mg, about 650 mg, about 655 mg, about 660 mg, about 665 mg, about 670 mg, about 675 mg, about 680 mg, about 685 mg, about 690 mg, about 695 mg, or about 700 mg.

[0171] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, wherein the antibody, or antigen-binding fragment thereof, is administered in a concentration of 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 190 mg, 200 mg, 210 mg, 220 mg, 230 mg, 240 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg, 500 mg, 510 mg, 520 mg, 530 mg, 540 mg, 550 mg, 560 mg, 570 mg, 580 mg, 590 mg, 600 mg, 610 mg, 620 mg, 630 mg, 640 mg, 6 5mg, 160mg, 165mg, 170mg, 175mg, 180mg, 185mg, 190mg, 195mg, 200mg, 210mg, 215mg, 220mg, 225mg, 230mg, 235mg, 240mg, 245mg, 250mg, 255mg, 260mg, 265mg, 270mg, 275mg, 280mg, 285mg, 290mg, 295mg, 300mg, 310mg, 315mg, 320mg, 325mg, 330mg, 335mg, 340mg , 345mg, 350mg, 355mg, 360mg, 365mg, 370mg, 375mg, 380mg, 385mg, 390mg, 395mg, 400mg, 410mg, 415mg, 420mg, 425mg, 430mg, 435 mg, 440mg, 445mg, 450mg, 455mg, 460mg, 465mg, 470mg, 475mg, 480mg, 485mg, 490mg, 495mg, 500mg, 510mg, 515mg, 520mg, 525mg, 5 Present in an amount of 30mg, 535mg, 540mg, 545mg, 550mg, 555mg, 560mg, 565mg, 570mg, 575mg, 580mg, 585mg, 590mg, 595mg, 600mg, 610mg, 615mg, 620mg, 625mg, 630mg, 635mg, 640mg, 645mg, 650mg, 655mg, 660mg, 665mg, 670mg, 675mg, 680mg, 685mg, 690mg, 695mg, or 700mg.

[0172] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present in an amount of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, or 300 mg. In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof is present in an amount of about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 500 mg, or about 600 mg.

[0173] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, present at a dose of about 0.03 mg / kg to about 10 mg / kg, which may be 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60 mg, 65 mg, 70 mg, 75 mg, 80 mg, 85 mg, 90 mg, 95 mg, 100 mg, 110 mg, 115 mg, 120 mg, 125 mg, 130 mg, 135 mg, 140 mg, 145 mg, 150 mg, 155 mg, 160 mg, 165 mg, 170 mg, 175 mg, 180 mg, 185 mg, 185 mg, 190 mg, 195 mg, 200 mg, 200 mg, 210 mg, 215 mg, 220 mg, 225 mg, 230 mg, 235 mg, 240 mg, 245 mg, 250 mg, 255 mg, 260 mg, 265 mg, 270 mg, 275 mg, 280 mg, 285 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, 400 mg, 410 mg, 420 mg, 430 mg, 440 mg, 450 mg, 460 mg, 470 mg, 480 mg, 490 mg, 500 mg, 510 mg, 520 mg mg, 150mg, 155mg, 160mg, 165mg, 170mg, 175mg, 180mg, 185mg, 190mg, 195mg, 200mg, 210mg, 215mg, 220mg, 225mg, 230mg, 235mg, 240 mg, 245mg, 250mg, 255mg, 260mg, 265mg, 270mg, 275mg, 280mg, 285mg, 290mg, 295mg, 300mg, 310mg, 315mg, 320mg, 325mg, 330mg, 335 mg, 340mg, 345mg, 350mg, 355mg, 360mg, 365mg, 370mg, 375mg, 380mg, 385mg, 390mg, 395mg, 400mg, 410mg, 415mg, 420mg, 425mg, 430 mg, 435mg, 440mg, 445mg, 450mg, 455mg, 460mg, 465mg, 470mg, 475mg, 480mg, 485mg, 490mg, 495mg, 500mg, 510mg, 515mg, 520mg, 525 mg, 530mg, 535mg, 540mg, 545mg, 550mg, 555mg, 560mg, 565mg, 570mg, 575mg, 580mg, 585mg, 590mg, 595mg, 600mg, 610mg, 615mg, 620mg, 625mg, 630mg, 635mg, 640mg, 645mg, 650mg, 655mg, 660mg, 665mg, 670mg, 675mg, 680mg, 685mg, 690mg, 695mg, or 700mg.

[0174] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, present at a dose of about 0.03 mg / kg to about 10 mg / kg, which is present in an amount of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, or 300 mg.

[0175] In some embodiments, the pharmaceutical composition comprises an anti-TSLP-R antibody, or antigen-binding fragment thereof, present at a dose of about 0.03 mg / kg to about 10 mg / kg, which is present in an amount of about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 500 mg, or about 600 mg.

[0176] In some embodiments, to prepare pharmaceutical or sterile compositions of the anti-TSLP-R antibodies or fragments thereof provided herein, the antibodies or antigen-binding fragments thereof provided herein are mixed with a pharmaceutically acceptable carrier or excipient. See, e.g., Remington's Pharmaceutical Sciences and US Pharmacopeia: National Formulary, Mack Publishing Company, Easton, PA (1984).

[0177] Formulations of therapeutic and diagnostic agents may be prepared, for example, in the form of a lyophilized powder, a slurry, an aqueous solution, or a suspension, by mixing with an acceptable carrier, excipient, or stabilizer (see, e.g., Hardman, et al. (2001) Goodman and Gilman's The Pharmacological Basis of Therapeutics, McGraw-Hill, New York, NY; Gennaro (2000) Remington: The Science and Practice of Pharmacy, Lippincott, Williams, and Wilkins, New York, NY; Avis, et al. (eds.) (1993) Pharmaceutical Dosage Forms: Parenteral Medications, Marcel Dekker, NY; Lieberman, et al. (eds.) (1990) Pharmaceutical Dosage Forms: Tablets, Marcel Dekker, NY; Lieberman, et al. (eds.) (1990) Pharmaceutical Dosage Forms: (See Forms: Disperse Systems, Marcel Dekker, NY; Weiner and Kotkoskie (2000) Excipient Toxicity and Safety, Marcel Dekker, Inc., New York, NY). In some embodiments, NaCl or sucrose is added to the anti-TSLP-R antibody composition for tonicity. Additional agents, such as polysorbate 20 or polysorbate 80, may be added to enhance stability.

[0178] In some embodiments, the pharmaceutical composition may further comprise one or more pharmaceutically acceptable carriers, including, for example, ion exchangers, alumina, aluminum stearate, lecithin, serum proteins such as human serum albumin, buffer substances such as phosphates, acetates, succinates, sucrose, glycine, arginine, proline, histidine, glutamate, 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, sodium acetate, sodium succinate, sodium phosphate, histidine hydrochloride, glycine hydrochloride, arginine hydrochloride, proline hydrochloride, glutamic acid hydrochloride, zinc salts, colloidal silica, magnesium trisilicate, polyvinylpyrrolidone, cellulose-based substances, polyethylene glycol, sodium carboxymethylcellulose, polyacrylates, polyethylene-polyoxypropylene block polymers, and polyethylene glycol, or combinations thereof.

[0179] In some embodiments, the pharmaceutical compositions described herein include a buffer (e.g., a histidine, acetate, phosphate, or citrate buffer) and / or a stabilizer (e.g., human albumin), or the like, or a combination thereof. In some embodiments, a buffer is used to buffer the pH. In some embodiments, the pH of the pharmaceutical composition is about 4.4 to about 7.6. 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 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 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 about 5.0. In some embodiments, the pH of the pharmaceutical composition is about 5.1. In some embodiments, the pH of the pharmaceutical composition is about 5.2. In some embodiments, the pH of the pharmaceutical composition is about 5.3. In some embodiments, the pH of the pharmaceutical composition is about 5.4. In some embodiments, the pH of the pharmaceutical composition is about 5.5. In some embodiments, the pH of the pharmaceutical composition is about 5.6. In some embodiments, the pH of the pharmaceutical composition is about 5.7. In some embodiments, the pH of the pharmaceutical composition is about 5.8. In some embodiments, the pH of the pharmaceutical composition is about 5.9. In some embodiments, the pH of the pharmaceutical composition is about 6.0. In some embodiments, the pH of the pharmaceutical composition is about 6.1. In some embodiments, the pH of the pharmaceutical composition is about 6.2. In some embodiments, the pH of the pharmaceutical composition is about 6.3. In some embodiments, the pH of the pharmaceutical composition is about 6.4. In some embodiments, the pH of the pharmaceutical composition is about 6.5.

[0180] In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable buffer, and the pharmaceutically acceptable buffer is a phosphoric acid buffer, a citric acid buffer, an acetic acid buffer, a succinic acid buffer, a citrate buffer, an ascorbic acid buffer, a glutamic acid buffer, a lactate buffer, a maleic acid buffer, a trometamol buffer, and a gluconate buffer, an acetate buffer, a succinate buffer, a phosphate buffer, a histidine buffer, or any combination thereof.

[0181] In some embodiments, the pharmaceutical composition comprises a citrate buffer. In some embodiments, the pharmaceutical composition comprises an acetate buffer. In some embodiments, the pharmaceutical composition comprises a succinate buffer. In some embodiments, the pharmaceutical composition comprises a citrate buffer. In some embodiments, the pharmaceutical composition comprises an ascorbic acid buffer. In some embodiments, the pharmaceutical composition comprises a glutamate buffer. In some embodiments, the pharmaceutical composition comprises a lactate buffer. In some embodiments, the pharmaceutical composition comprises a maleate buffer. In some embodiments, the pharmaceutical composition comprises a trometamol buffer. In some embodiments, the pharmaceutical composition comprises a gluconate buffer. In some embodiments, the pharmaceutical composition comprises an acetate buffer. In some embodiments, the pharmaceutical composition comprises a succinate buffer. In some embodiments, the pharmaceutical composition comprises a phosphate buffer. In some embodiments, the pharmaceutical composition comprises a histidine buffer.

[0182] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L phosphate buffer.

[0183] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L phosphate buffer.

[0184] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L citrate buffer.

[0185] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L citrate buffer.

[0186] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L acetate buffer.

[0187] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L acetate buffer.

[0188] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L succinate buffer.

[0189] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L succinate buffer.

[0190] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L citrate buffer.

[0191] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L citrate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L citrate buffer.

[0192] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L ascorbic acid buffer.

[0193] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L ascorbic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L ascorbic acid buffer.

[0194] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L glutamate buffer.

[0195] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L glutamate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L glutamate buffer.

[0196] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L lactate buffer.

[0197] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L lactate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L lactate buffer.

[0198] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L maleic acid buffer.

[0199] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L maleic acid buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L maleic acid buffer.

[0200] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L trometamol buffer.

[0201] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L trometamol buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L trometamol buffer.

[0202] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L gluconate buffer.

[0203] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L gluconate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L gluconate buffer.

[0204] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L acetate buffer.

[0205] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L acetate buffer.

[0206] In some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable buffer, wherein the pharmaceutically acceptable buffer is an acetate buffer, which may be, but is not limited to, sodium acetate, potassium acetate, or magnesium acetate, or any combination thereof. In some embodiments, the pharmaceutical composition comprises a sodium acetate buffer. In some embodiments, the pharmaceutical composition comprises a potassium acetate buffer. In some embodiments, the pharmaceutical composition comprises a magnesium acetate buffer.

[0207] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L potassium acetate buffer.

[0208] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L potassium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L potassium acetate buffer.

[0209] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L magnesium acetate buffer.

[0210] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L magnesium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L magnesium acetate buffer.

[0211] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L sodium acetate buffer.

[0212] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L sodium acetate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L sodium acetate buffer.

[0213] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L succinate buffer.

[0214] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L succinate buffer.

[0215] In some embodiments, the succinate buffer is about 5 mmol / L to about 100 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L sodium succinate buffer.

[0216] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L sodium succinate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L sodium succinate buffer.

[0217] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L phosphate buffer.

[0218] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L phosphate buffer.

[0219] In some embodiments, the phosphate buffer is sodium phosphate. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L sodium phosphate buffer.

[0220] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L sodium phosphate buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L sodium phosphate buffer.

[0221] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 100 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 70 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 50 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L to about 60 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L to about 40 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L to about 30 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is 15 mmol / L to about 25 mmol / L histidine buffer.

[0222] In some embodiments, the pharmaceutically acceptable buffer is about 5 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 10 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 15 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 20 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 25 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 30 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 35 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 40 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 45 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 50 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 55 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 60 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 75 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 80 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 85 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 90 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 95 mmol / L histidine buffer. In some embodiments, the pharmaceutically acceptable buffer is about 100 mmol / L histidine buffer.

[0223] One of the major stresses that proteins (e.g., antibodies) can face is interfacial stress (e.g., from the air / water interface in a liquid composition or the ice / water interface during freezing / thawing). Surfactants are typically used to stabilize proteins in biopharmaceutical compositions under stress or during long-term storage to prevent or minimize aggregation and / or particle formation. Examples of surfactants include anionic surfactants (e.g., ammonium lauryl sulfate, sodium lauryl sulfate, sodium laureth sulfate, sodium myreth sulfate, dioctyl sodium sulfosuccinate, perfluorooctane sulfonate, perfluorobutane sulfonate, 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 chloride). cocamidopropyl ammonium bromide), zwitterionic (amphoteric) surfactants (e.g., 3-[(3-cholamidopropyl)dimethylammonio]-l-propanesulfonate, cocamidopropyl hydroxysultaine, phosphatidylserine, phosphatidylethanolamine, phosphatidylcholine, sphingomyelin, lauryldimethylamine oxide, and myristamine oxide), nonionic surfactants (e.g., polysorbates or Brij series), ethoxylates (e.g., fatty alcohol ethoxylates (e.g., octaethylene glycol monododecyl ether and pentaethylene glycol monododecyl ether), alkylphenol ethoxylates (e.g., nonoxynol and TritonX-100), fatty acid ethoxylates, ethoxylated amines and / or fatty acid amides (e.g., polyethoxylated tallow amine, cocamide monoethanolamine, and cocamide diethanolamine), endblocked ethoxylates (e.g., poloxamers), 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 polyglucosides (e.g., decyl glucoside, lauryl glucoside, and octyl glucoside), or combinations thereof.

[0224] In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is a polysorbate or a poloxamer.

[0225] In some embodiments, the pharmaceutical composition comprises a polysorbate, wherein the polysorbate is polysorbate 20 (PS20) or polysorbate 80 (PS80).

[0226] PS80 is also known as polyoxyethylene (20) sorbitan monooleate and has the following formula: [ka]

[0227] PS20 is also known as polyoxyethylene (20) sorbitan monolaurate and has the following formula: [ka]

[0228] 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 (poly(ethylene oxide)). In some embodiments, the pharmaceutical composition comprises a poloxamer, wherein the poloxamer is poloxamer 188, poloxamer 407, poloxamer 184, poloxamer 124, or a combination thereof. In some embodiments, the pharmaceutical composition comprises poloxamer 188. In some embodiments, the pharmaceutical composition comprises poloxamer 407. In some embodiments, the pharmaceutical composition comprises poloxamer 184. In some embodiments, the pharmaceutical composition comprises poloxamer 124.

[0229] In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.001% (w / v) to about 1% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.01% (w / v) to about 0.5% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.01% (w / v) to about 0.1% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.02% (w / v) to about 0.05% (w / v).

[0230] In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.01% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.02% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.03% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.04% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.05% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.1% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.15% (w / v). In some embodiments, the pharmaceutical composition comprises a surfactant, wherein the surfactant is present at a concentration of about 0.2% (w / v).

[0231] In some embodiments, PS20 is present at a concentration of about 0.01% (w / v). In some embodiments, PS20 is present at a concentration of about 0.02% (w / v). In some embodiments, PS20 is present at a concentration of about 0.03% (w / v). In some embodiments, PS20 is present at a concentration of about 0.04% (w / v). In some embodiments, PS20 is present at a concentration of about 0.05% (w / v). In some embodiments, PS20 is present at a concentration of about 0.05% (w / v). In some embodiments, PS20 is present at a concentration of about 0.1% (w / v). In some embodiments, PS20 is present at a concentration of about 0.15% (w / v). In some embodiments, PS20 is present at a concentration of about 0.2% (w / v).

[0232] In some embodiments, PS80 is present at a concentration of about 0.01% (w / v). In some embodiments, PS80 is present at a concentration of about 0.02% (w / v). In some embodiments, PS80 is present at a concentration of about 0.03% (w / v). In some embodiments, PS80 is present at a concentration of about 0.04% (w / v). In some embodiments, PS80 is present at a concentration of about 0.05% (w / v). In some embodiments, PS80 is present at a concentration of about 0.1% (w / v). In some embodiments, PS80 is present at a concentration of about 0.15% (w / v). In some embodiments, PS80 is present at a concentration of about 0.2% (w / v).

[0233] In some embodiments, poloxamer 188 is present at a concentration of about 0.01% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.02% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.03% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.04% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.1% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.15% (w / v). In some embodiments, poloxamer 188 is present at a concentration of about 0.2% (w / v).

[0234] In some embodiments, poloxamer 407 is present at a concentration of about 0.01% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.02% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.03% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.04% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.1% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.15% (w / v). In some embodiments, poloxamer 407 is present at a concentration of about 0.2% (w / v).

[0235] In some embodiments, poloxamer 184 is present at a concentration of about 0.01% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.02% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.03% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.04% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.1% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.15% (w / v). In some embodiments, poloxamer 184 is present at a concentration of about 0.2% (w / v).

[0236] In some embodiments, poloxamer 124 is present at a concentration of about 0.01% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.02% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.03% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.04% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.05% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.1% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.15% (w / v). In some embodiments, poloxamer 124 is present at a concentration of about 0.2% (w / v).

[0237] In some embodiments, the pharmaceutical composition comprises an excipient. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 1 mmol / L to about 600 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 1 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 50 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 110 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 120 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 130 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 140 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 150 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 160 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 170 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 180 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 190 mmol / L to about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 200 mmol / L.

[0238] In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 110 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 120 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 130 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 140 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 150 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 160 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 170 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 180 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 170 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 180 mmol / L.

[0239] In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 180 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 170 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 100 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 120 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 130 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 140 mmol / L.

[0240] In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 110 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 120 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 130 mmol / L.

[0241] In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 100 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 110 mmol / L to about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 120 mmol / L.

[0242] In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 1 mmol / L to about 100 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 1 mmol / L to about 90 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 1 mmol / L to about 80 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 1 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 30 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 40 mmol / L to about 60 mmol / L. In some embodiments, the pharmaceutical composition includes an excipient, and the excipient is present at a concentration of about 50 mmol / L.

[0243] In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 1 mmol / L to about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 10 mmol / L to about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, wherein the excipient is present at a concentration of about 20 mmol / L.

[0244] In some embodiments, the excipient is present at a concentration of about 600 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 500 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 400 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 300 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 250 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 220 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 200 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 180 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 160 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 140 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 120 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 100 mmol / L or less. In some embodiments, the excipient is present at a concentration of about 50 mmol / L or less, hi some embodiments, the excipient is present at a concentration of about 20 mmol / L or less.

[0245] In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 10 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 20 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 50 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 75 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 110 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 120 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 220 mmol / L, hi some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 250 mmol / L.In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 400 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 500 mmol / L. In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is present at a concentration of about 600 mmol / L.

[0246] In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is an amino acid. In some embodiments, the excipient is histidine, glycine, arginine, proline, or glutamate, or a pharmaceutically acceptable salt thereof, or any combination thereof. In some embodiments, the excipient is a combination of any two or more of histidine, glycine, arginine, proline, or glutamate, or a pharmaceutically acceptable salt thereof.

[0247] In some embodiments, the pharmaceutical composition comprises an excipient, and the excipient is glycine, arginine, or proline, or a pharmaceutically acceptable salt thereof. In some embodiments, the excipient is glycine, or a pharmaceutically acceptable salt thereof. In some embodiments, the excipient is glutamate, or a pharmaceutically acceptable salt thereof. In some embodiments, the excipient is arginine, or a pharmaceutically acceptable salt thereof. In some embodiments, the excipient is histidine, or a pharmaceutically acceptable salt thereof. In some embodiments, the excipient is proline, or a pharmaceutically acceptable salt thereof.

[0248] In some embodiments, the excipient is a buffering agent. In some embodiments, the buffering agent is histidine.

[0249] In some embodiments, the excipient is a viscosity-lowering agent, hi some embodiments, the viscosity-lowering agent is histidine, glycine, arginine, proline, or glutamate, or a pharmaceutically acceptable salt thereof, or any combination thereof.

[0250] In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof. Histidine is an essential amino acid that can be represented by the formula:

[0251] [ka]

[0252] 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, such as histidine hydrochloride. In some embodiments, a pharmaceutically acceptable salt of histidine is 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 enantiomerically pure L-histidine. In some embodiments, the histidine is pharmaceutical grade histidine.

[0253] In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 600 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 150 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 220 mmol / L, hi some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 220 mmol / L.In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 190 mmol / L to about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.

[0254] In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L.

[0255] In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L.

[0256] In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L.

[0257] In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L.

[0258] In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 90 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 80 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L to about 60 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 50 mmol / L.

[0259] In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 10 mmol / L to about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 20 mmol / L.

[0260] In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 600 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 500 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 400 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 300 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 250 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 220 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 200 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 180 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 160 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 140 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 120 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 100 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 50 mmol / L or less. In some embodiments, histidine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 20 mmol / L or less.

[0261] In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 10 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 20 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 75 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 190 mmol / L, hi some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 400 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 500 mmol / L. In some embodiments, the pharmaceutical composition comprises histidine, or a pharmaceutically acceptable salt thereof, at a concentration of about 600 mmol / L.

[0262] In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof. Glycine is an amino acid that can be represented by the formula:

[0263] [ka]

[0264] Glycine, as used herein, includes the free base form of glycine as well as any and all salts thereof. In some embodiments, glycine includes its pharmaceutically acceptable salts, such as glycine hydrochloride. In some embodiments, a pharmaceutically acceptable salt of glycine is 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 enantiomerically pure L-glycine. In some embodiments, the glycine is pharmaceutical grade glycine.

[0265] In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 600 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 160 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 220 mmol / L, hi some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L to about 220 mmol / L.In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 190 mmol / L to about 210 mmol / L, hi some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.

[0266] In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L.

[0267] In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L.

[0268] In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L.

[0269] In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L.

[0270] In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 90 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 80 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L to about 60 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L.

[0271] In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 10 mmol / L to about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 20 mmol / L.

[0272] In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 600 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 500 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 400 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 300 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 250 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 220 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 200 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 180 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 160 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 140 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 120 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 100 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 50 mmol / L or less. In some embodiments, glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 20 mmol / L or less.

[0273] In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 10 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 20 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 75 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 400 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 500 mmol / L. In some embodiments, the pharmaceutical composition comprises glycine or a pharmaceutically acceptable salt thereof at a concentration of about 600 mmol / L.

[0274] In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof. Arginine is a conditionally non-essential amino acid that can be represented by the formula:

[0275] [ka]

[0276] As used herein, arginine includes the free base form of arginine as well as any and all salts thereof. In some embodiments, arginine includes its pharmaceutically acceptable salt, for example, arginine hydrochloride. In some embodiments, the pharmaceutically acceptable salt of arginine is arginine hydrochloride.

[0277] Arginine, as used herein, also includes all enantiomers (e.g., L-arginine and S-arginine), as well as any combination of enantiomers (e.g., 50% L-arginine and 50% S-arginine, 90%-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 enantiomerically pure L-arginine. In some embodiments, the arginine is pharmaceutical grade arginine.

[0278] In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 600 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 220 mmol / L, hi some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 220 mmol / L.In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 190 mmol / L to about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.

[0279] In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L.

[0280] In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L.

[0281] In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L.

[0282] In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 110 mmol / L to about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L.

[0283] In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 90 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 80 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L to about 60 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 50 mmol / L.

[0284] In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 10 mmol / L to about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 20 mmol / L.

[0285] In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 600 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 500 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 400 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 300 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 250 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 220 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 200 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 180 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 160 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 140 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 120 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 100 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 50 mmol / L or less. In some embodiments, arginine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 20 mmol / L or less.

[0286] In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 10 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 20 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 75 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 120 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 210 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 400 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 500 mmol / L. In some embodiments, the pharmaceutical composition comprises arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 600 mmol / L.

[0287] In some embodiments, the viscosity-lowering agent is proline, or a pharmaceutically acceptable salt thereof. Proline is an amino acid that can be represented by the formula:

[0288] [ka]

[0289] 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, such as proline hydrochloride. In some embodiments, a pharmaceutically acceptable salt of proline is 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 enantiomerically pure L-proline. In some embodiments, the proline is pharmaceutical grade proline.

[0290] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 600 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 300 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 250 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 160 mmol / L to about 220 mmol / L. In some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 220 mmol / L, hi some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L to about 220 mmol / L.In some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 190 mmol / L to about 210 mmol / L, hi some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 200 mmol / L.

[0291] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 140 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 150 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 160 mmol / L to about 200 mmol / L. In some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 170 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L.

[0292] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 190 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 180 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 170 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 160 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 140 mmol / L.

[0293] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 130 mmol / L.

[0294] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 150 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 100 mmol / L to about 140 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 110 mmol / L to about 130 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 120 mmol / L.

[0295] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 100 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 90 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 80 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 30 mmol / L to about 70 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 40 mmol / L to about 60 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 50 mmol / L.

[0296] In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 1 mmol / L to about 40 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 10 mmol / L to about 30 mmol / L. In some embodiments, the pharmaceutical composition comprises proline or a pharmaceutically acceptable salt thereof at a concentration of about 20 mmol / L.

[0297] In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 600 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 500 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 400 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 300 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 250 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 220 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 200 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 180 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 160 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 140 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 120 mmol / L or less. In some embodiments, proline, or a pharmaceutically acceptable salt thereof, is present at a concent...

Claims

1. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) an excipient at a concentration of about 1 mmol / L to about 600 mmol / L; (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v); The pharmaceutical composition comprising:

2. (i) a heavy chain CDR1, CDR2, and CDR3 sequence, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9, or a variant of any of the foregoing. a heavy chain variable region comprising: (ii) a light chain CDR1, CDR2, and CDR3 sequence, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12, or a variant of any of the foregoing. a light chain variable region comprising 2. The pharmaceutical composition of claim 1, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises:

3. 3. The pharmaceutical composition of claim 1 or 2, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable 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:5, with the proviso that the heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO:7, SEQ ID NO:8, and SEQ ID NO:

9.

4. 4. The pharmaceutical composition of any one of claims 1 to 3, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises a variable 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:6, with the proviso that the light chain polypeptide comprises the amino acid sequence of SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:

12.

5. the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) a variable heavy chain polypeptide having a sequence at least 95% identical to the sequence of SEQ ID NO:5, provided that the heavy chain polypeptide comprises the amino acid sequence of SEQ ID NO:7, SEQ ID NO:8, and SEQ ID NO:9; and (ii) a variable light chain polypeptide having a sequence at least 95% identical to the sequence of SEQ ID NO:6, provided that the light chain polypeptide comprises the amino acid sequence of SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:

12.

2. The pharmaceutical composition of claim 1, comprising:

6. the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) a variable heavy chain polypeptide having the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having the sequence of SEQ ID NO:6 6. The pharmaceutical composition of claim 5, comprising:

7. 10. The pharmaceutical composition of claim 1, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 1 mg / mL to about 300 mg / mL, about 50 mg / mL to about 250 mg / mL, about 100 mg / mL to about 200 mg / mL, or about 150 mg / mL to about 200 mg / mL.

8. 2. The pharmaceutical composition of claim 1, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 25 mg / mL, about 50 mg / mL, about 100 mg / mL, about 125 mg / mL, about 150 mg / mL, about 175 mg / mL, about 200 mg / mL, about 225 mg / mL, about 250 mg / mL, about 275 mg / mL, or about 300 mg / mL.

9. 10. The pharmaceutical composition of claim 1, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 150 mg / mL.

10. 10. The pharmaceutical composition of claim 1, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 200 mg / mL.

11. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable buffer is a histidine buffer.

12. 12. The pharmaceutical composition of claim 11, wherein the histidine buffer is present at a concentration of about 5 mmol / L to about 100 mmol / L, about 5 mmol / L to about 70 mmol / L, about 5 mmol / L to about 60 mmol / L, about 10 mmol / L to about 60 mmol / L, about 10 mmol / L to about 50 mmol / L, about 10 mmol / L to about 40 mmol / L, about 15 mmol / L to about 30 mmol / L, or about 15 mmol / L to about 25 mmol / L.

13. 13. The pharmaceutical composition of claim 11 or 12, wherein the histidine buffer is present at a concentration of about 20 mmol / L.

14. 14. The pharmaceutical composition of any one of claims 1-13, wherein the excipient is a viscosity-lowering agent and is present at a concentration of about 1 mmol / L to about 600 mmol / L, about 50 mmol / L to about 300 mmol / L, about 100 mmol / L to about 250 mmol / L, about 120 mmol / L to about 200 mmol / L, about 130 mmol / L to about 200 mmol / L, about 140 mmol / L to about 200 mmol / L, about 150 mmol / L to about 200 mmol / L, about 160 mmol / L to about 200 mmol / L, about 170 mmol / L to about 200 mmol / L, or about 180 mmol / L to about 200 mmol / L.

15. 15. The pharmaceutical composition according to any one of claims 1 to 14, wherein the excipient is an amino acid selected from glycine, glutamate, arginine, histidine, proline, or a pharmaceutically acceptable salt thereof.

16. 16. The pharmaceutical composition of any one of claims 1 to 15, wherein the excipient is glycine, arginine, or proline, or a pharmaceutically acceptable salt thereof.

17. 13. The pharmaceutical composition of any one of claims 1 or 5-12, wherein the excipient is glycine, or a pharmaceutically acceptable salt thereof.

18. 17. The pharmaceutical composition of any one of claims 1 to 16, wherein the excipient is arginine, or a pharmaceutically acceptable salt thereof.

19. The pharmaceutical composition of any one of claims 1 to 16, wherein the excipient is proline, or a pharmaceutically acceptable salt thereof.

20. 2. The pharmaceutical composition of claim 1, wherein the surfactant is a polysorbate or a poloxamer.

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

22. 21. The pharmaceutical composition of claim 20, wherein the poloxamer is poloxamer 188.

23. 23. The pharmaceutical composition of any one of claims 20-22, wherein the surfactant is present at a concentration of about 0.001% to about 1%, about 0.01% to about 0.5%, about 0.01% to about 0.1%, or about 0.02% to about 0.05% (w / v).

24. 23. The pharmaceutical composition of any one of claims 20-22, wherein the surfactant is present at a concentration of about 0.01%, about 0.02%, about 0.03%, about 0.04%, or about 0.05% (w / v).

25. 25. The pharmaceutical composition of any one of claims 1 to 24, wherein the pH of the pharmaceutical composition is from about 5.0 to about 6.

5.

26. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 600 mmol / L; (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v); The pharmaceutical composition comprising:

27. (i) a heavy chain CDR1, CDR2, and CDR3 sequence, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9, or a variant of any of the foregoing. a heavy chain variable region comprising: (ii) a light chain CDR1, CDR2, and CDR3 sequence, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 sequence has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 12, or a variant of any of the foregoing. a light chain variable region comprising 27. The pharmaceutical composition of claim 26, wherein the anti-TSLP-R antibody, or antigen-binding fragment thereof, comprises:

28. the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) a variable heavy chain polypeptide having the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having the sequence of SEQ ID NO:6 27. The pharmaceutical composition of claim 26, comprising:

29. 29. The pharmaceutical composition of claim 28, wherein the antibody, or antigen-binding fragment thereof, is present at a concentration of about 150 mg / mL or about 200 mg / mL.

30. 27. The pharmaceutical composition of claim 26, wherein the pharmaceutically acceptable buffer is a histidine buffer.

31. 31. The pharmaceutical composition of claim 30, wherein the histidine buffer is present at a concentration of about 20 mmol / L.

32. 31. The pharmaceutical composition of claim 30, wherein the glycine, or a pharmaceutically acceptable salt thereof, is present at a concentration of about 180 mmol / L.

33. 27. The pharmaceutical composition of claim 26, wherein the surfactant is a polysorbate or a poloxamer.

34. 34. The pharmaceutical composition of claim 33, wherein the polysorbate is polysorbate 20 (PS20) or polysorbate 80 (PS80).

35. 35. The pharmaceutical composition of claim 34, wherein the polysorbate is polysorbate 80 (PS80).

36. 36. The pharmaceutical composition of claim 35, wherein the surfactant is present at a concentration of about 0.001% to about 1%, about 0.01% to about 0.5%, about 0.01% to about 0.1%, or about 0.02% to about 0.05% (w / v).

37. 36. The pharmaceutical composition of claim 35, wherein the surfactant is present at a concentration of about 0.01%, about 0.02%, about 0.03%, about 0.04%, or about 0.05% (w / v).

38. 35. The pharmaceutical composition of claim 34, wherein the surfactant is PS80 and the PS80 is present at a concentration of about 0.03% (w / v).

39. (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL to about 250 mg / mL; (ii) a histidine buffer solution at a concentration of about 10 mmol / L to about 30 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 150 mmol / L to about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.7; 27. The pharmaceutical composition of claim 26, comprising:

40. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 600 mmol / L; (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v); The pharmaceutical composition comprising:

41. the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) a variable heavy chain polypeptide having the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having the sequence of SEQ ID NO:6 41. The pharmaceutical composition of claim 40, comprising:

42. (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL to about 250 mg / mL; (ii) a histidine buffer solution at a concentration of about 10 mmol / L to about 30 mmol / L; (iii) arginine, or a pharmaceutically acceptable salt thereof, at a concentration of about 100 mmol / L to about 150 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.7; Including, the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) a variable heavy chain polypeptide having the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having the sequence of SEQ ID NO:6 41. The pharmaceutical composition of claim 40, comprising:

43. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 1 mg / mL to about 300 mg / mL; (ii) a pharmaceutically acceptable buffer at a concentration of about 5 mmol / L to about 100 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 1 mmol / L to about 600 mmol / L; (iv) a surfactant at a concentration of about 0.001% to about 1% (w / v); The pharmaceutical composition comprising:

44. (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 150 mg / mL to about 250 mg / mL; (ii) a histidine buffer solution at a concentration of about 10 mmol / L to about 30 mmol / L; (iii) proline, or a pharmaceutically acceptable salt thereof, at a concentration of about 150 mmol / L to about 200 mmol / L; (iv) polysorbate 80 at a concentration of about 0.01% to about 0.05% (w / v); and (v) a pH of about 5.7; Including, the anti-TSLP-R antibody, or antigen-binding fragment thereof, (i) a variable heavy chain polypeptide having the sequence of SEQ ID NO:5, and (ii) a variable light chain polypeptide having the sequence of SEQ ID NO:6 44. The pharmaceutical composition of claim 43, comprising:

45. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of 180 mg / mL to 220 mg / mL; (ii) a histidine buffer solution having a concentration of 18 mmol / L to 22 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of 160 mmol / L to 200 mmol / L; (iv) polysorbate 80 at a concentration of 0.01% (w / v) to 0.05% (w / v); (v) a pH of 5.6 to 5.8; Including, the anti-TSLP-R antibody, or antigen-binding fragment thereof, (a) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO:

12. The pharmaceutical composition comprising:

46. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a concentration of about 200 mg / mL; (ii) a histidine buffer solution at a concentration of about 20 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7; Including, the anti-TSLP-R antibody, or antigen-binding fragment thereof, (a) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO:

12. The pharmaceutical composition comprising:

47. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of 0.03 mg / kg to 10 mg / kg; (ii) a histidine buffer solution having a concentration of 18 mmol / L to 22 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of 160 mmol / L to 200 mmol / L; (iv) polysorbate 80 at a concentration of 0.01% (w / v) to 0.05% (w / v); (v) a pH of 5.6 to 5.8; Including, the anti-TSLP-R antibody, or antigen-binding fragment thereof, (a) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO:

12. The pharmaceutical composition comprising:

48. 1. A pharmaceutical composition comprising: (i) an anti-TSLP-R antibody, or antigen-binding fragment thereof, at a dose of 0.03 mg / kg to 10 mg / kg; (ii) a histidine buffer solution at a concentration of about 20 mmol / L; (iii) glycine, or a pharmaceutically acceptable salt thereof, at a concentration of about 180 mmol / L; (iv) polysorbate 80 at a concentration of about 0.03% (w / v); and (v) a pH of about 5.7; Including, the anti-TSLP-R antibody, or antigen-binding fragment thereof, (a) a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 sequences, wherein the heavy chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 7, the heavy chain CDR2 has the amino acid sequence of SEQ ID NO: 8, and the heavy chain CDR3 sequence has the amino acid sequence of SEQ ID NO: 9; and (b) a light chain variable region comprising light chain CDR1, CDR2, and CDR3 sequences, wherein the light chain CDR1 sequence has the amino acid sequence of SEQ ID NO: 10, the light chain CDR2 has the amino acid sequence of SEQ ID NO: 11, and the light chain CDR3 sequence has the amino acid sequence of SEQ ID NO:

12. The pharmaceutical composition comprising:

49. 49. The pharmaceutical composition of any one of claims 1 to 48, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 1 and a light chain comprising the amino acid sequence of SEQ ID NO:

3.

50. A pharmaceutical dosage form comprising the pharmaceutical composition of any one of claims 1 to 49.

51. 51. The pharmaceutical dosage form of claim 50, wherein the dosage form is suitable for subcutaneous, intravenous, or intramuscular injection.

52. 50. A method for treating a disease in a subject in need thereof, comprising administering to said subject a therapeutically effective amount of the pharmaceutical composition of any one of claims 1 to 49.

53. 53. The method of claim 52, wherein the pharmaceutical composition or pharmaceutical dosage form is administered about every 1 week, about every 2 weeks, about every 3 weeks, about every 4 weeks, about every 5 weeks, about every 6 weeks, about every 7 weeks, about every 8 weeks, about every 9 weeks, about every 10 weeks, about every 11 weeks, about every 12 weeks, about every 13 weeks, about every 14 weeks, about every 15 weeks, about every 16 weeks, about every 17 weeks, about every 18 weeks, about every 19 weeks, about every 20 weeks, about every 21 weeks, about every 22 weeks, about every 23 weeks, or about every 24 weeks.

54. the pharmaceutical composition or pharmaceutical dosage form comprises the antibody, or antigen-binding fragment thereof, present in an amount of about 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, or about 625 mg; 54. The method of claim 52 or 53, wherein the pharmaceutical composition or pharmaceutical dosage form is administered about every 1 week, about every 2 weeks, about every 3 weeks, about every 4 weeks, about every 5 weeks, about every 6 weeks, about every 7 weeks, about every 8 weeks, about every 9 weeks, about every 10 weeks, about every 11 weeks, about every 12 weeks, about every 13 weeks, about every 14 weeks, about every 15 weeks, about every 16 weeks, about every 17 weeks, about every 18 weeks, about every 19 weeks, about every 20 weeks, about every 21 weeks, about every 22 weeks, about every 23 weeks, or about every 24 weeks.

55. 55. The method of any one of claims 52-54, wherein the pharmaceutical composition or pharmaceutical dosage form comprises the antibody, or antigen-binding fragment thereof, present in an amount of about 25 mg, about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, or about 300 mg, and wherein the pharmaceutical composition or pharmaceutical dosage form is administered about every 4 weeks.

56. 55. The method of any one of claims 52-54, wherein the pharmaceutical composition or pharmaceutical dosage form comprises the antibody, or antigen-binding fragment thereof, present in an amount of about 25 mg, about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, or about 300 mg, and wherein the pharmaceutical composition or pharmaceutical dosage form is administered about every 8 weeks.

57. 55. The method of any one of claims 52-54, wherein the pharmaceutical composition or pharmaceutical dosage form comprises the antibody, or antigen-binding fragment thereof, present in an amount of about 25 mg, about 50 mg, about 100 mg, about 150 mg, about 200 mg, about 250 mg, or about 300 mg, and wherein the pharmaceutical composition or pharmaceutical dosage form is administered about every 12 weeks.

58. 55. The method of any one of claims 52-54, wherein the pharmaceutical composition or pharmaceutical dosage form comprises the antibody, or antigen-binding fragment thereof, present in an amount of about 200 mg, about 250 mg, about 300 mg, about 350 mg, about 400 mg, about 500 mg, or about 600 mg, and wherein the pharmaceutical composition or pharmaceutical dosage form is administered about every 24 weeks.

59. 55. The method of any one of claims 52 to 54, wherein the subject in need thereof has a disease selected from the list consisting of a pulmonary disease, a digestive disease, a neoplastic disease, a skin disease, a kidney disease, an allergy, or an immune disease.

60. 60. The method of any one of claims 52 to 59, wherein the disease is asthma or systemic sclerosis.

61. 61. The method of any one of claims 52 to 60, wherein the composition is administered subcutaneously, intravenously, or intramuscularly.

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