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) 50 mg/ml of a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα
- ) antibody, wherein the antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO;
1and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO;
2;
(b) a polyol;
(c) a polysorbate; and
(d) a buffer system comprising an organic acid;
wherein the formulation has a pH of 4 to 8, and wherein 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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Citations
30 Claims
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1. A stable liquid aqueous pharmaceutical formulation comprising
(a) 50 mg/ml of a human IgG1 anti-human Tumor Necrosis Factor alpha (TNFα - ) antibody, wherein the antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO;
1and a heavy chain variable region comprising the amino acid sequence of SEQ ID NO;
2;(b) a polyol; (c) a polysorbate; and (d) a buffer system comprising an organic acid; wherein the formulation has a pH of 4 to 8, 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, wherein the antibody comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO;
Specification