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US 8,940,305 B2Granted
Formulation of human antibodies for treating TNF-α associated disorders
AssigneeAbbVie Biotechnology Ltd.
InventorsHans-Juergen Krause, Lisa Baust, Michael Dickes
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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.
Claims30
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.
2 more elements
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.
2 more elements
Dependencies are inferred from the claim text.