High concentration antibody and protein formulations
AssigneesGenentech, Inc., Novartis AG
InventorsJun LIU, Steven J. SHIRE
Life of this patent
Estimating the term…
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.
Claims29
A stable, liquid formulation of low turbidity comprising (a) a protein or antibody in an amount of 100 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, (d) polysorbate in an amount of 0.01 to 0.1%, where the formulation further has a pH ranging from 5.5 to 7.0, a kinematic viscosity of about 50 cs or less and osmolarity ranging from 200 mOsm/kg to 450 mOsm/kg.
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A stable, liquid formulation of low turbidity comprising (a) an anti-IgE monoclonal antibody in an amount of 100 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, (d) polysorbate in an amount of 0.01 to 0.1%, where the formulation further has a pH ranging from 5.5 to 7.0, a kinematic viscosity of about 50 cs or less and osmolarity ranging from 200 mOsm/kg to 450 mOsm/kg.
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A stable, liquid formulation of low turbidity comprising (a) an anti-IgE antibody 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, (d) polysorbate in an amount of 0.02%, where the formulation further has a pH of 6.0.
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Dependencies are inferred from the claim text.