Antibody formulations
AssigneeGenentech, Inc.
InventorsLan LE, Brian Connolly
Life of this patent
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Abstract
The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations.
Claims33
A stable aqueous pharmaceutical formulation, the formulation comprising a monoclonal antibody, trehalose, and a buffer, wherein the weight ratio of said monoclonal antibody to said trehalose in the formulation is 0.49 to 1.47, 0.41 to 0.73, or 0.73 to 1.47;
- wherein the formulation has a pH of about 5.5 to about 7.0, wherein the monoclonal antibody binds VEGF and wherein said monoclonal antibody is bevacizumab.
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A stable aqueous pharmaceutical formulation, the formulation comprising (a) a monoclonal antibody in an amount of about 25 mg/mL to about 100 mg/mL;
- (b) trehalose in an amount of about 45 mM to about 634 mM;
- and (c) sodium phosphate in an amount of greater than about 35 mM to about 100 mM, wherein said formulation has a pH of about 5.5 to about 7.0, wherein the weight ratio of said monoclonal antibody to said trehalose in the formulation is 0.49 to 1.47, 0.41 to 0.73, or 0.73 to 1.47, wherein the monoclonal antibody binds VEGF, and wherein said monoclonal antibody is bevacizumab.
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A method of reducing aggregation of a therapeutic monoclonal antibody, comprising formulating said antibody in a formulation comprising trehalose in an amount of about 45 mM to about 634 mM and sodium phosphate in an amount of greater than 35 mM to about 100 mM, and said formulation having a pH of about 5.5 to about 7.0, wherein said monoclonal antibody is formulated in an amount of about 25 mg/mL to about 100 mg/mL in the formulation, wherein the weight ratio of said monoclonal antibody to said trehalose in the formulation is greater than or equal to 0.41 and less than 1.65, wherein the monoclonal antibody binds VEGF and wherein said monoclonal antibody is bevacizumab.
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A method of reducing aggregation of a therapeutic monoclonal antibody, comprising formulating said antibody in a formulation comprising trehalose and a buffer, wherein the weight ratio of said monoclonal antibody to said trehalose in the formulation is greater than or equal to 0.41 and less than 1.65, wherein the formulation has a pH of about 5.5 to about 7.0, wherein the monoclonal antibody binds VEGF and wherein said monoclonal antibody is bevacizumab.
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A stable aqueous pharmaceutical formulation for intravenous administration, the formulation comprising (a) a monoclonal antibody in an amount of less than or equal to about 100 mg/mL;
- and (b) trehalose in an amount of about 50 mM to about 600 mM, wherein said formulation has a pH of about 5.5 to about 7.0, and wherein the weight ratio of said monoclonal antibody to said trehalose in the formulation is greater than or equal to 0.41 and less than 1.65.
A stable aqueous pharmaceutical formulation for subcutaneous or intraocular administration, the formulation comprising (a) a monoclonal antibody in an amount of less than or equal to about 100 mg/mL;
- and (b) trehalose in an amount of about 150 mM to about 400 mM, wherein said formulation has a pH of about 5.5 to about 7.0, and wherein the weight ratio of said monoclonal antibody to said trehalose in the formulation is greater than or equal to 0.41 and less than 1.65.
Dependencies are inferred from the claim text.