Reduced-viscosity concentrated protein formulations

Abstract

The present application concerns concentrated protein formulations with reduced viscosity, which are particularly suitable for subcutaneous administration. The application further concerns a method for reducing the viscosity of concentrated protein formulations.

1 - 43 . (canceled) 
     
     
         44 . A method of reducing the viscosity of a formulation containing high concentration of a protein comprising either lowering the pH to about 4.2 to about 5.3 or lowering the pH to about 6.5 to about 12.0. 
     
     
         45 . The method of  claim 44  wherein said protein is present in an amount of at least about 80 mg/ml. 
     
     
         46 . The method of  claim 44  wherein said protein is a member of the immunoglobulin gene superfamily. 
     
     
         47 . The method of  claim 46  wherein said protein is an immunoglobulin. 
     
     
         48 . The method of  claim 47  wherein said immunoglobulin is an antibody directed against a specific antigen. 
     
     
         49 . The method of  claim 48  wherein said antibody is directed against IgE. 
     
     
         50 . The method of  claim 49  wherein the antibody is rhuMAb-E25, rhuMAb-E26 or rhuMAb-E27. 
     
     
         51 . The method of  claim 50  wherein said formulation is a reconstituted formulation. 
     
     
         52 . The method of  claim 51  wherein the protein concentration m said reconstituted formulation is about 2-40 times greater than the protein concentration in the mixture before lyophilization. 
     
     
         53 . The method of  claim 52  wherein the viscosity of said formulation is reduced to about 50 cs or less. 
     
     
         54 - 55 . (canceled) 
     
     
         56 . The method of  claim 53 , wherein the viscosity of said formulation is reduced to about 2 to 30 cs. 
     
     
         57 . The method of  claim 44  further comprising adding a pharmaceutically acceptable acid, base or buffer in the amount of at least about 10 mM. 
     
     
         58 . The method of  claim 57 , wherein the acid, base or buffer is in an amount of about 50-200 mM. 
     
     
         59 . The method of  claim 58 , wherein the acid, base or buffer is selected from the group consisting of acetic acid, hydrochloric acid and arginine.