IP Library › Patent Application 16057217
Patent Application
App. No. 16/057,217

FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS

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Quick Facts
Patent No.
US None
App. No.
16/057,217
Abstract

A liquid aqueous pharmaceutical formulation is described which has a high protein concentration, a pH of between about 4 and about 8, and enhanced stability.

Claims (8)

1 . A stable liquid aqueous pharmaceutical formulation comprising

(a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα) antibody at a concentration of 50 mg/ml,

(b) 12 mg/ml mannitol,

(c) 1 mg/ml polysorbate 80, and

(d) a buffer system comprising citrate and having a pH of 5.0 to 5.2,

wherein the antibody is D2E7, and wherein the formulation is suitable for subcutaneous injection.

2 . The formulation of claim 1 , wherein the formulation further comprises sodium chloride.

3 . The formulation of claim 1 , wherein the formulation further comprises 6.2 mg/ml sodium chloride.