Stable liquid pharmaceutical formulation of igg antibodies

Abstract

This invention is directed to a stable liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg/ml or more, of antibody in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, having pH from about pH 5.5 to about pH 6.5, about 0.01-0.1% polysorbate, and a tonicity modifier that contributes to the isotonicity of the formulation. This liquid formulation is stable at refrigerated temperature (2-8° C.) for at least 1 year, and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. The preferred antibodies include Daclizumab, a humanized anti-IL-2 receptor monoclonal antibody; HAIL-12, a humanized anti-IL-12 monoclonal antibody; HuEP5C7, a humanized anti-L selectin monoclonal antibody; and Flintozumab, a humanized anti-gamma interferon monoclonal antibody.

1 . A stable liquid pharmaceutical formulation comprising:
 20-60 mM succinate buffer having pH of pH 5.5 to pH 6.5,   0.02%-0.04% polysorbate,   75-150 mM sodium chloride, and   a Daclizumab antibody, wherein said antibody has a concentration of 50 mg/ml or more.   
     
     
         2 . The stable liquid pharmaceutical formulation according to  claim 1 , wherein said antibody has a concentration of 100 mg/ml or more. 
     
     
         3 . The stable liquid pharmaceutical formulation according to  claim 1 , wherein the concentration of succinate buffer is 30-50 mM. 
     
     
         4 . The stable liquid pharmaceutical formulation according to  claim 1 , which is for parenteral administration. 
     
     
         5 . The stable liquid pharmaceutical formulation according to  claim 1 , which is for subcutaneous administration. 
     
     
         6 . The stable liquid pharmaceutical formulation according to  claim 1 , wherein the concentration of succinate buffer is 30-60 mM.