Formulation of human antibodies for treating TNF-α 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, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml,(b) a polyol,(c) a surfactant, and(d) a buffer system having a pH of 4 to 8,wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7.
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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, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml,
(b) a polyol, (c) a surfactant, and (d) a buffer system having a pH of 4 to 8, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7. - 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, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml,
Specification