High concentration antibody and protein formulations
AssigneeGenentech, Inc.
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.
Claims14
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, and (d) polysorbate in an amount of 0.01 to 0.1%, and where the formulation further has a pH of 6.0;
- wherein the anti-IgE antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO:1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:4.
An article of manufacture comprising a container enclosing 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, and (d) polysorbate in an amount of 0.01 to 0.1%, and where the formulation further has a pH of 6.0;
- wherein the anti-IgE antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO:1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:4.
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, and (d) polysorbate in an amount of 0.01 to 0.1%, and where the formulation further has a pH of 6.0;
- wherein the anti-IgE antibody is produced by a method comprising
- (1) culturing cells transformed or transfected with a vector containing nucleic acid encoding an antibody comprising a light chain comprising the amino acid sequence of SEQ ID NO:1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:4, and
- (2) purifying the antibody produced by the cells.
An article of manufacture comprising a container enclosing 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, and (d) polysorbate in an amount of 0.01 to 0.1%, and where the formulation further has a pH of 6.0;
- wherein the anti-IgE antibody is produced by a method comprising
- (1) culturing cells transformed or transfected with a vector containing nucleic acid encoding an antibody comprising a light chain comprising the amino acid sequence of SEQ ID NO:1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:4, and
- (2) purifying the antibody produced by the cells.
Dependencies are inferred from the claim text.