Antibody formulation
AssigneeGenentech, Inc.
InventorsYatin R. Gokarn, Timothy J. Kamerzell, Megan Li, Mary Cromwell, Hong Liu
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Abstract
The invention provides a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, optionally, not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.0 to about 6.0, and an optional surfactant, methods for making such a formulation, and methods of using such a formulation.
Claims70
A stable aqueous pharmaceutical formulation, the formulation comprising a therapeutically effective amount of an antibody in an arginine buffer, pH 4.0 to 6.0.
An article of manufacture comprising a container holding a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, an arginine acetate buffer from about pH 4.5 to about 6.0, and a surfactant.
A method for stabilizing an antibody in an aqueous pharmaceutical formulation by combining a therapeutically effective amount of an antibody, an arginine acetate buffer from about pH 4.5 to about 6.0, and a surfactant.
A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, 200 mM arginine acetate buffer at pH 5.2, and a surfactant.
A pharmaceutical formulation comprising:
- (a) a full length IgG1 antibody susceptible to deamidation or aggregation in an amount from about 10 mg/mL to about 250 mg/mL;
- (b) arginine acetate buffer, pH 4.5 to 6.0;
- and (c) polysorbate 20 in an amount from about 0.01% to about 0.1%.
A method for reducing aggregation of a therapeutic monoclonal antibody, comprising formulating the antibody in an arginine acetate buffer, pH 4.5 to 6.0.
A pharmaceutical formulation comprising an antibody that binds to VEGF in an arginine acetate buffer at a pH from about 4.5 to about 6.0, and a surfactant.
Dependencies are inferred from the claim text.