Antibody formulation

Abstract

The invention provides a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, optionally, not subjected to prior lyophilization, a buffer maintaining the pH in the range from about 4.0 to about 6.0, and an optional surfactant, methods for making such a formulation, and methods of using such a formulation.

1 . A stable aqueous pharmaceutical formulation, the formulation comprising a therapeutically effective amount of an antibody in an arginine buffer, pH 4.0 to 6.0. 
     
     
         2 - 4 . (canceled) 
     
     
         5 . The formulation of wherein the arginine actetate concentration in the buffer is from about 25 mM to about 250 mM. 
     
     
         6 - 11 . (canceled) 
     
     
         12 . The formulation of  claim 1 , further comprising a surfactant. 
     
     
         13 - 14 . (canceled) 
     
     
         15 . The formulation of  claim 12 , wherein the surfactant concentration is from 0.0001% to about 1.0%. 
     
     
         16 - 17 . (canceled) 
     
     
         18 . The formulation of  claim 1 , wherein the antibody concentration is from about 10 mg/ml to about 250 mg/ml. 
     
     
         19 - 21 . (canceled) 
     
     
         22 . The formulation of  claim 1 , wherein the antibody is not subject to prior lyophilization. 
     
     
         23 - 32 . (canceled) 
     
     
         33 . The formulation of  claim 1  wherein the buffer is 200 mM arginine acetate pH 5.2, the surfactant is polysorbate in an amount of about 0.01-0.1% v/v, wherein the formulation is stable at a temperature of about 40° C. for at least 28 days 
     
     
         34 . An article of manufacture comprising a container holding a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, an arginine acetate buffer from about pH 4.5 to about 6.0, and a surfactant. 
     
     
         35 - 36 . (canceled) 
     
     
         37 . A method for stabilizing an antibody in an aqueous pharmaceutical formulation by combining a therapeutically effective amount of an antibody, an arginine acetate buffer from about pH 4.5 to about 6.0, and a surfactant. 
     
     
         38 - 39 . (canceled) 
     
     
         40 . A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, 200 mM arginine acetate buffer at pH 5.2, and a surfactant. 
     
     
         41 - 42 . (canceled) 
     
     
         43 . An article of manufacture comprising a container holding the formulation of  claim 40 . 
     
     
         44 . (canceled) 
     
     
         45 . The formulation of  claim 1  which is stable upon storage at about 40° C. for at least 28 days. 
     
     
         46 . The formulation of  claim 1  which is aqueous and is administered to a subject. 
     
     
         47 - 51 . (canceled) 
     
     
         52 . A vial with a stopper pierceable by a syringe comprising the formulation of  claim 1  inside the vial. 
     
     
         53 - 54 . (canceled) 
     
     
         55 . A stainless steel tank comprising the formulation of  claim 1  inside the tank. 
     
     
         56 . (canceled) 
     
     
         57 . A method of treating a disease or disorder in a subject comprising administering the formulation of  claim 1  to a subject in an amount effective to treat the disease or disorder. 
     
     
         58 - 59 . (canceled) 
     
     
         60 . A pharmaceutical formulation comprising: (a) a full length IgG1 antibody susceptible to deamidation or aggregation in an amount from about 10 mg/mL to about 250 mg/mL; (b) arginine acetate buffer, pH 4.5 to 6.0; and (c) polysorbate 20 in an amount from about 0.01% to about 0.1%. 
     
     
         61 - 62 . (canceled) 
     
     
         63 . A method for reducing aggregation of a therapeutic monoclonal antibody, comprising formulating the antibody in an arginine acetate buffer, pH 4.5 to 6.0. 
     
     
         64 - 67 . (canceled) 
     
     
         68 . A method of making a pharmaceutical formulation comprising:
 (a) preparing the formulation of  claim 1 ; and   (b) evaluating physical stability, chemical stability, or biological activity of the antibody in the formulation.   
     
     
         69 - 70 . (canceled)