Antibody formulations
Formulations comprising an anti-IL-13 antibody are provided, including pharmaceutical formulations and methods of using such formulations.
1. A method of administering subcutaneously a formulation, wherein the formulation is within an article of manufacture comprising the formulation and a subcutaneous administration device; wherein the formulation comprises an anti-IL13 antibody, wherein the concentration of the anti-IL-13 antibody in the formulation is at least 100 mg/mL and the viscosity of the formulation is less than 15 centipoise (cP) at 25° C., wherein the formulation comprises a histidine acetate buffer, pH 5.4 to 6.0, and the histidine acetate concentration in the buffer is between 5 mM and 40 mM, and wherein the anti-IL-13 antibody is an IgG4 antibody and comprises three heavy chain CDRs, CDR-H1 having the amino acid sequence of SEQ ID NO: 1, CDR-H2 having the amino acid sequence of SEQ ID NO: 2, and CDR-H3 having the amino acid sequence of SEQ ID NO: 3, and three light chain CDRs, CDR-L1 having the amino acid sequence of SEQ ID NO: 4, CDR-L2 having the amino acid sequence of SEQ ID NO: 5, and CDR-L3 having the amino acid sequence of SEQ ID NO: 6.
2. The method of claim 1 , wherein the formulation has extended stability.
3. The method of claim 1 , wherein the formulation comprises 20 mM histidine acetate buffer, pH 5.7, 175 mM sucrose, and 0.03% polysorbate 20, wherein the concentration of the anti-IL-13 antibody in the formulation is 125 mg/mL.
4. The method of claim 3 , wherein the subcutaneous administration device comprises a prefilled syringe.
5. The method of claim 3 , wherein the subcutaneous administration device comprises an autoinjector.
6. The method of claim 3 , wherein the subcutaneous administration device comprises an injector pen.
7. The method of claim 1 , wherein the formulation comprises 20 mM histidine acetate buffer, pH 5.7, 175 mM sucrose, and 0.03% polysorbate 20, wherein the concentration of the anti-IL-13 antibody in the formulation is 150 mg/mL.
8. The method of claim 7 , wherein the subcutaneous administration device comprises a prefilled syringe.
9. The method of claim 8 , wherein the syringe comprises low tungsten borosilicate glass.
10. The method of claim 7 , wherein the subcutaneous administration device comprises an autoinjector.
11. The method of claim 7 , wherein the subcutaneous administration device comprises an injector pen.
12. The method of claim 1 , wherein the subcutaneous administration device comprises a prefilled syringe.
13. The method of claim 12 , wherein the syringe comprises low tungsten borosilicate glass.
14. The method of claim 1 , wherein the subcutaneous administration device comprises an autoinjector.
15. The method of claim 1 , wherein the subcutaneous administration device comprises an injector pen.
16. The method of claim 1 , wherein the anti-IL13 antibody comprises a VH having the amino acid sequence of SEQ ID NO: 7 or 8, and a VL having the amino acid sequence of SEQ ID NO: 9.
17. The method of claim 1 , wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of any one of SEQ ID NO: 10, 11, 12, or 13, and a light chain having the amino acid sequence of SEQ ID NO: 14.
18. The method of claim 1 , wherein the concentration of the anti-IL-13 antibody in the formulation is between 100 mg/mL and 150 mg/mL.