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, or an antigen-binding portion thereof, at a concentration of 45 to 105 mg/ml,(b) a polyol,(c) a polysorbate at a concentration of 0.1 to 10 mg/ml, and(d) a buffer system comprising histidine and having a pH of 4.5 to 7.0,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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Citations
29 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 45 to 105 mg/ml,
(b) a polyol, (c) a polysorbate at a concentration of 0.1 to 10 mg/ml, and (d) a buffer system comprising histidine and having a pH of 4.5 to 7.0, 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, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- ) antibody, or an antigen-binding portion thereof, at a concentration of 45 to 105 mg/ml,
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7. A stable liquid aqueous pharmaceutical formulation comprising
(a) 45 to 105 mg/ml of a human IgG1 anti-human Tumor Necrosis Factor alpha (hTNFα - ) antibody,
(b) a polyol, (c) 0.1-10 mg/ml of polysorbate 80, and (d) a buffer system comprising histidine and having a pH of 4.5 to 7.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
- ) antibody,
Specification