High concentration antibody and protein formulations

Abstract

The present application relates to highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity. The formulations are particularly suitable for subcutaneous administration. The application further describes articles of manufacture containing such formulations and method for using them to treat disorders treatable by the formulated antibody or protein.

1 .- 50 . (canceled) 
     
     
         51 . A stable, liquid formulation of low turbidity comprising (a) an antibody in an amount of about 100 to about 260 mg/ml, (b) arginine HCl in an amount of about 50 to about 200 mM, and (c) histidine in an amount of about 10 to about 100 mM, and wherein the formulation further has a pH of about 5.5 to about 7.0. 
     
     
         52 . The stable, liquid formulation of  claim 51 , wherein the antibody is in an amount of about 120 to 260 mg/ml. 
     
     
         53 . The stable, liquid formulation of  claim 51 , wherein the antibody is in an amount of about 150 to 260 mg/ml. 
     
     
         54 . The stable, liquid formulation of  claim 51 , wherein the antibody is in an amount of about 150 mg/ml. 
     
     
         55 . The stable, liquid formulation of  claim 51 , wherein the arginine HCL is at a concentration of about 50 to about 100 mM. 
     
     
         56 . The stable, liquid formulation of  claim 51 , wherein the arginine HCl is at a concentration of about 50 mM. 
     
     
         57 . The stable, liquid formulation of  claim 51 , wherein the histidine is at a concentration of about 20 mM. 
     
     
         58 . The stable, liquid formulation of  claim 51 , wherein the histidine is at a concentration of about 23 mM. 
     
     
         59 . The stable, liquid formulation of  claim 51 , where the formulation further comprises sucrose. 
     
     
         60 . The stable, liquid formulation of  claim 51 , wherein the sucrose is at a concentration from about 30 mM to about 300 mM. 
     
     
         61 . The stable, liquid formulation of  claim 51 , wherein the formulation further comprises polysorbate. 
     
     
         62 . The stable, liquid formulation of  claim 61 , wherein the polysorbate is polysorbate 20. 
     
     
         63 . The stable liquid formulation of  claim 51 , wherein the pH of the formulation is about 6. 
     
     
         64 . The stable liquid formulation of  claim 51 , wherein the antibody is a monoclonal antibody. 
     
     
         65 . An article of manufacture comprising a container enclosing the formulation of  claim 51 . 
     
     
         66 . The article of manufacture of  claim 65 , wherein the container is a syringe. 
     
     
         67 . The article of manufacture of  claim 66 , wherein the syringe is further contained within an injection device. 
     
     
         68 . The article of manufacture of  claim 67 , wherein the injection device is an auto-injector.