Anti-CD19 antibody preparations

Abstract

To provide a stable, lyophilized antibody drug formulation for use in the reconstitution of liquid formulations. [Solution] A stable lyophilized pharmaceutical preparation for use in the reconstitution of liquid preparations, wherein the liquid preparation contains an anti-CD19 antibody at a concentration of 20 mg / ml to 125 mg / ml, a citrate buffer at a concentration of 20 to 50 mM, and a polysorbate at a concentration of 0.005% (w / v) to 0.06% (w / v), and has a pH of 6.0, and further comprises a) trehalose at a concentration of 180 mM to 240 mM, or b) mannitol at a concentration of 180 mM to 240 mM and sucrose at a concentration of 10 mM to 50 mM, and is a stable lyophilized pharmaceutical preparation.

Claims

1. A stable lyophilized pharmaceutical preparation comprising an anti-CD19 antibody at a concentration of 20 mg / ml to 125 mg / ml, a buffer, a polysorbate at a concentration of 0.005% (w / v) to 0.06% (w / v), and a pH of 6.0, a) Trehalose at a concentration of 180 mM to 240 mM, b) Mannitol at a concentration of 180 mM to 240 mM and sucrose at a concentration of 10 mM to 50 mM. The anti-CD19 antibody further comprises the sequence The heavy chain constant domain and sequence A stable lyophilized pharmaceutical formulation characterized by containing a light chain constant domain.

2. The formulation according to claim 1, characterized in that the anti-CD19 antibody in the formulation is 40 mg / ml.

3. A formulation according to claim 1 or 2, characterized in that the buffer is a citrate buffer or a phosphate buffer.

4. The formulation according to claim 3, characterized in that the citrate buffer or phosphate buffer has a concentration of 20 to 50 mM.

5. The formulation according to claim 4, characterized in that the citrate buffer or phosphate buffer has a concentration of 25 mM.

6. A formulation according to any one of claims 1 to 5, characterized in that the trehalose in the formulation is 200 mM.

7. A formulation according to any one of claims 1 to 5, characterized in that the mannitol in the formulation is 219 mM and the sucrose in the formulation is 29 mM.

8. A formulation according to any one of claims 1 to 7, characterized in that the polysorbate in the formulation is polysorbate 20.

9. A formulation according to any one of claims 1 to 8, characterized in that the amount of polysorbate in the formulation is 0.02%.

10. A formulation according to any one of claims 1 to 9, characterized in that the anti-CD19 antibody is an IgG1, IgG2, IgG3, or IgG4 antibody.

11. A formulation according to any one of claims 1 to 10, characterized in that it is stable at 2 to 8°C for at least 6 months, at least 12 months, at least 18 months, at least 24 months, or at least 36 months.

12. A formulation according to any one of claims 1 to 5, characterized in that the anti-CD19 antibody is in an amount of 40 mg / mL, the citrate buffer is at a concentration of 25 mM, the trehalose is at a concentration of 200 mM, the polysorbate is at a concentration of 0.02% (w / v), and the formulation has a pH of 6.

0.

13. A formulation according to any one of claims 1 to 5, wherein the anti-CD19 antibody is present in an amount of 40 mg / mL, the citrate buffer is present at a concentration of 25 mM, the mannitol is present at a concentration of 219 mM, the sucrose is present at a concentration of 29 mM, the polysorbate is present at a concentration of 0.02% (w / v), and the formulation has a pH of 6.

0.

14. A product characterized by including a container for holding a stable lyophilized pharmaceutical preparation according to any one of claims 1 to 13.

15. A method for treating a disease or disorder in a subject, comprising the step of administering an effective amount of a preparation according to any one of claims 1 to 13 to the subject, wherein the disease or disorder is cancer.

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