Antibody formulations

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.

What is claimed is: 
     
         1 . A stable aqueous pharmaceutical formulation, the formulation comprising:
 a. a monoclonal antibody Fab fragment in an amount of about 25 mg/ml to about 100 mg/ml, which Fab fragment binds VEGF;   b. trehalose in an amount of about 40 mM to about 120 mM; and   c. a histidine buffer, wherein said formulation has a pH of about 5.5 to about 7.0.   
     
     
         2 . The formulation of  claim 1 , further comprising a surfactant. 
     
     
         3 . The formulation of  claim 2  wherein said surfactant is polysorbate or poloxamer. 
     
     
         4 . The formulation of  claim 3  wherein said polysorbate is polysorbate 20. 
     
     
         5 . The formulation of  claim 4  wherein the polysorbate 20 concentration is about 0.01% to about 0.1% 
     
     
         6 . The formulation of  claim 1  or  3  wherein histidine is in an amount of about 15 mM to about 35 mM. 
     
     
         7 . The formulation of  claim 1  wherein the Fab fragment is in an amount of about 30 mg/ml to about 90 mg/ml. 
     
     
         8 . The formulation of  claim 1  wherein the Fab fragment is in an amount of about 35 mg/ml to about 75 mg/ml. 
     
     
         9 . The formulation of  claim 1  wherein the Fab fragment is in an amount of about 40 mg/ml. 
     
     
         10 . The formulation of  claim 1  or  3  wherein the Fab fragment is in an amount of about 40 mg/ml, wherein trehalose is in an amount of 120 mM, wherein histidine is in an amount of 15 mM and wherein said formulation has a pH of about 5.5. 
     
     
         11 . The formulation of  claim 4  wherein the Fab fragment is in an amount of about 40 mg/ml, wherein trehalose is in an amount of 120 mM, wherein histidine is in an amount of 15 mM, wherein the concentration of polysorbate 20 is 0.01% and wherein the formulation has a pH of about 5.5. 
     
     
         12 . The formulation of  claim 1 ,  3  or  11  wherein the weight ratio of monoclonal Fab fragment to trehalose is about 1.65 to about 3.30. 
     
     
         13 . The formulation of  claim 1 ,  3  or  11  wherein the weight ratio of monoclonal Fab fragment to trehalose is about 1.65.