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 citrate and phosphate 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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20 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 citrate and phosphate 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)
- ) antibody at a concentration of 50 mg/ml,
Specification