Low concentration antibody formulations
AssigneeGlaxosmithkline Intellectual Property (No.2) Limited
InventorsGeorge Crotts, Sorina Morar-Mitrica
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Abstract
The present invention is directed formulations for low concentrations of therapeutic proteins and methods of making the same. In one aspect the present invention is directed to a formulation for a therapeutic protein comprising: a) the therapeutic protein; and b) a surfactant; wherein the molar ratio of surfactant to therapeutic protein is at least 100. In another aspect the present invention is directed to a formulation for a therapeutic protein comprising: a) the therapeutic protein; and b) an antioxidant, wherein the molar ratio of antioxidant to therapeutic protein is at least 750.
Claims14
A formulation for a therapeutic protein comprising:
- a) the therapeutic protein, which is an antigen binding protein or fragment thereof, at a concentration of about 0.01 mg/mL to about 1 mg/mL;
- b) a surfactant;
- and c) an antioxidant, wherein the molar ratio of surfactant to therapeutic protein is at least 100, wherein the molar ratio of antioxidant to therapeutic protein is at least 750, and wherein the antioxidant is selected from the group consisting of methionine, cysteine, glutathione, and monothioglycerol.
A formulation for a therapeutic protein comprising:
- a) the therapeutic protein, which is an antigen binding protein or fragment thereof, at a concentration of about 0.01 mg/mL to about 1 mg/mL;
- and b) 0.01% w/v to 0.5% w/v surfactant, wherein the molar ratio of surfactant to therapeutic protein is at least 100;
- c) 1 mM to 50 mM antioxidant, wherein the molar ratio of antioxidant to therapeutic protein is at least 750;
- and d) 1 mM to 100 mM buffer, wherein the pH of the formulation is 4.0 to 8.0.
Dependencies are inferred from the claim text.