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 comprising gluconate and having a pH of 4.0 to 8.0,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 comprising gluconate and having a pH of 4.0 to 8.0, 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)
- ) antibody, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml,
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22. A stable liquid aqueous pharmaceutical formulation comprising
(a) 20 to 150 mg/ml of a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα - ) antibody,
(b) a polyol, (c) a polysorbate, and (d) a buffer system comprising gluconate and having a pH of 4.0 to 8.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30)
- ) antibody,
Specification