Purified antibody composition

Abstract

The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

1 . A method of treating a disorder in which TNFα activity is detrimental comprising administering to a human subject in need thereof a liquid pharmaceutical composition comprising adalimumab and a pharmaceutically acceptable carrier, wherein the adalimumab is expressed in a Chinese hamster ovary (CHO) cell expression system; and the composition is characterized in that when the composition is assayed in a cathepsin L kinetic assay, a level of fluorescent activity no greater than 0.0144 RFU/sec is observed, wherein the cathepsin L kinetic assay comprises:
 i. diluting the composition 600-fold in a polystyrene container in a solution containing 25 mM NaOAc, 5 mM DTT and 1 mM EDTA at pH 5.5, 
 ii. adding dextran sulfate to a concentration of 0.035 μg/mL and incubating at 37° C. for six hours, 
 iii. adding Z-leucine-arginine covalently bound at its C-terminus to a fluorescent 7-amino-4-methyl coumarin (Z-leucine-arginine-AMC), wherein the diluting, adding, and incubating steps are sufficient to permit the measurement of cathepsin L hydrolysis of the Z-leucine-arginine-AMC within a linear range, and 
 iv. measuring the fluorescent activity generated by the Z-leucine-arginine-AMC hydrolysis. 
 
     
     
         2 . The method of  claim 1 , wherein the composition comprises a therapeutically effective amount of adalimumab. 
     
     
         3 . The method of  claim 2 , wherein the composition comprises 20, 40, or 80 mg of adalimumab. 
     
     
         4 . The method of  claim 2 , wherein no detectable level of fluorescent activity is observed. 
     
     
         5 . The method of  claim 2 , wherein the composition is packaged in a pre-filled syringe. 
     
     
         6 . The method of  claim 2 , wherein the composition is suitable for subcutaneous injection. 
     
     
         7 . The method of  claim 2 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection. 
     
     
         8 . The method of  claim 3 , wherein the composition comprises 20 mg of adalimumab. 
     
     
         9 . The method of  claim 8 , wherein no detectable level of fluorescent activity is observed. 
     
     
         10 . The method of  claim 8 , wherein the composition is packaged in a pre-filled syringe. 
     
     
         11 . The method of  claim 8 , wherein the composition is suitable for subcutaneous injection. 
     
     
         12 . The method of  claim 8 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection. 
     
     
         13 . The method of  claim 3 , wherein the composition comprises 40 mg of adalimumab. 
     
     
         14 . The method of  claim 13 , wherein no detectable level of fluorescent activity is observed. 
     
     
         15 . The method of  claim 13 , wherein the composition is packaged in a pre-filled syringe. 
     
     
         16 . The method of  claim 13 , wherein the composition is suitable for subcutaneous injection. 
     
     
         17 . The method of  claim 13 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection. 
     
     
         18 . The method of  claim 3 , wherein the composition comprises 80 mg of adalimumab. 
     
     
         19 . The method of  claim 18 , wherein no detectable level of fluorescent activity is observed. 
     
     
         20 . The method of  claim 18 , wherein the composition is packaged in a pre-filled syringe. 
     
     
         21 . The method of  claim 18 , wherein the composition is suitable for subcutaneous injection. 
     
     
         22 . The method of  claim 18 , wherein no detectable level of fluorescent activity is observed, wherein the composition is packaged in a pre-filled syringe, and wherein the composition is suitable for subcutaneous injection.