ANTIBODY FORMULATIONS
Formulations of anti-VLA-1 antibodies are described.
1 - 30 . (canceled)
31 . A method of treating a subject comprising subcutaneously administering to said subject an aqueous pharmaceutical composition comprising an anti-Very Late Antigen-1 (VLA-1) antibody at a concentration of about 100 mg/ml to about 225 mg/ml and at least one buffer,
wherein said anti-VLA-1 antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO: 4 and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 5, and
wherein said at least one buffer is selected from one or more of at least one histidine buffer, at least one acetate buffer, at least one succinate buffer, at least one citrate buffer, at least one glutamate buffer, and at least one phosphate buffer.
32 . The method of claim 31 , wherein the aqueous pharmaceutical composition further comprises at least one additional excipient at a concentration of about 100 mM to about 300 mM.
33 . The method of claim 32 , wherein the at least one additional excipient is selected from one or more of sorbitol, sodium chloride, sucrose, trehalose, and mannitol.
34 . The method of claim 31 , wherein the aqueous pharmaceutical composition further comprises at least one surfactant at a concentration of about 0.001% to about 0.5%.
35 . The method of claim 31 , wherein the aqueous pharmaceutical composition further comprises at least one additional excipient and at least one surfactant.
36 . The method of claim 35 , wherein the at least one surfactant is at least one polysorbate.
37 . The method of claim 36 , wherein the at least one polysorbate is polysorbate 80 or polysorbate 20.
38 . The method of claim 31 , wherein the at least one histidine buffer at a concentration of about 10 mM to about 50 mM.
39 . The method of claim 31 , wherein the at east one histidine buffer is present at a concentration of about 20 mM to about 40 mM.
40 . The method of claim 31 , wherein the aqueous pharmaceutical composition comprises an anti-VLA-1 antibody at a concentration of at least about 150 mg/ml.
41 . The method of claim 31 , wherein the anti-VIA-1 antibody comprises a light chain and a heavy chain, wherein the amino acid sequence of the light chain is the same as or differs by no more than 10 amino acids from the sequence of SEQ ID NO:1 and wherein the amino acid sequence of the heavy chain is the same as or differs by no more than 10 amino acids from the sequence of SEQ ID NO:2.
42 . The method of claim 31 , wherein the anti-VLA-1 antibody comprises a light chain and a heavy chain, wherein the amino acid sequence of the light chain is that of SEQ NO:1 and the amino acid sequence of the heavy chain is that of SEQ ID NO:2.
43 . The method of claim 31 , wherein the subject has an inflammatory disorder.
44 . The method of claim 31 , wherein the inflammatory disorder is arthritis, rheumatoid arthritis, inflammatory bowel disease, lupus, transplant rejection, psoriasis, fibrosis, or Crohn's disease.
45 . The method of claim 44 , wherein the inflammatory disorder is rheumatoid arthritis.
46 . The method of claim 44 , wherein the inflammatory disorder is inflammatory bowel disease.
47 . The method of claim 31 , wherein the aqueous pharmaceutical composition is suitable for subcutaneous administration to a subject in need thereof.
48 . The method of claim 31 , wherein the aqueous pharmaceutical composition is stable after storage at 2° C. to 8° C. for at least 3 years as indicated by <15% impurities as assessed by reducing capillary electrophoresis sodium dodecyl sulfate (CE-SDS).
49 . The method of claim 31 , wherein the aqueous pharmaceutical composition is stable after storage at 2° C. to 8° C. for at least 3 years, as indicated by the presence of less than 10% total aggregation as assessed by size exclusion chromatography.
50 . The method of claim 31 , wherein the aqueous pharmaceutical composition stable after storage at 2° C. to 8° C. for at least 3 years as indicated by less than 5% total aggregation as assessed by size exclusion chromatography.
51 . The method of claim 31 , wherein the aqueous pharmaceutical composition is stable after storage at 2° C. to 8° C. for at least 48 months.