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 human anti-human Tumor Necrosis Factor alpha (TNFα
) IgG1 antibody at a concentration of 50 mg/ml, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7, and a buffer system;
wherein the formulation is isotonic, suitable for single-use subcutaneous injection, and has a pH of 4.0 to 8.0.
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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 human anti-human Tumor Necrosis Factor alpha (TNFα
) IgG1 antibody at a concentration of 50 mg/ml, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7, and a buffer system;wherein the formulation is isotonic, suitable for single-use subcutaneous injection, and has a pH of 4.0 to 8.0. - 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)
- a human anti-human Tumor Necrosis Factor alpha (TNFα
Specification