High concentration antibody and protein formulations
AssigneesGenentech, Inc., Novartis AG
InventorsJun Liu, Steven J. Shire
Life of this patent
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Abstract
The present application relates to highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity. The formulations are particularly suitable for subcutaneous administration. The application further describes articles of manufacture containing such formulations and method for using them to treat disorders treatable by the formulated antibody or protein.
Claims24
A method of treating an IgE-mediated disorder comprising administrating to a patient in need thereof a therapeutically effective amount of a stable, liquid formulation of low turbidity comprising (a) anti-IgE antibody rhuMAbE25 in an amount of 150 to 260 mg/ml, (b) arginine-HCl in an amount of 50 to 200 mM, (c) histidine in an amount of 10 to 100 mM, and (d) polysorbate in an amount of 0.01 to 0.1%, wherein the formulation further has a pH ranging from 5.5 to 7.0.
A method of treating an IgE-mediated disorder comprising administrating to a patient in need thereof a therapeutically effective amount of a stable, liquid formulation of low turbidity comprising (a) anti-IgE antibody rhuMAbE25 in an amount of about 150 mg/ml, (b) arginine-HCl in an amount of 200 mM, (c) histidine in an amount of 20 mM, and (d) polysorbate in an amount of 0.01 to 0.1%, wherein the formulation further has a pH of 6.0.
Dependencies are inferred from the claim text.