Formulation of human antibodies for treating TNF-alpha associated disorders
First Claim
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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) a polyol,(c) a polysorbate, and(d) a buffer system comprising gluconate and having a pH of 4 to 8,wherein the antibody is D2E7, andwherein the formulation is suitable for subcutaneous injection.
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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.
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30 Claims
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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) a polyol, (c) a polysorbate, and (d) a buffer system comprising gluconate and having a pH of 4 to 8, wherein the antibody is D2E7, and wherein the formulation is suitable for subcutaneous injection. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
- ) antibody at a concentration of 50 mg/ml,
Specification