Antibody formulation

Abstract

The present invention relates to pharmaceutical formulations of a pharmaceutically active antigen binding protein, for example a monoclonal antibody. Such formulations comprise, in addition to the antigen binding protein, a buffering agent and a tonicity agent.

We claim: 
     
         1 . A pharmaceutical formulation for an antigen binding protein comprising:
 a. 200 mg/mL antigen binding protein;   b. 10 mM of a buffering agent which is histidine providing a pH of 6.0±0.5;   c. 115 mM of a tonicity agent which is sodium chloride;   d. 25 mM of a stabilizer which is L-arginine hydrochloride; and   e. 0.01% (w/v) of a nonionic surfactant which is polysorbate 80;   
       wherein the antigen binding protein is a monoclonal antibody or fragment thereof and comprises amino acid sequences CDRH1 of SEQ ID NO:11, CDRH2 of SEQ ID NO: 12, CDRH3 of SEQ ID NO:13, CDRL1 of SEQ ID NO:14, CDRL2 of SEQ ID NO:15, and CDRL3 of SEQ ID NO:16. 
     
     
         2 . The pharmaceutical formulation according to  claim 1  which is stable upon freezing and thawing. 
     
     
         3 . The pharmaceutical formulation according to  claim 1  for subcutaneous or intramuscular administration. 
     
     
         4 . The pharmaceutical formulation according to  claim 1  wherein the antigen binding protein retains >90% relative potency after storage at 2-8° C. for 3 months. 
     
     
         5 . The pharmaceutical formulation according to  claim 1  wherein the formulation provides an acceptable delivery force to allow delivery using a 29G thin wall or wider needle. 
     
     
         6 . The pharmaceutical formulation according to  claim 1  wherein the deamidation rate is ≤0.2%/month at 2-8° C. 
     
     
         7 . A method of treating systemic lupus erythematosus in a human comprising administering to said human a formulation according to  claim 1 . 
     
     
         8 . A method of treating systemic lupus erythematosus in a human comprising administering to said human a formulation according to  claim 3 .