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 - 70 . (canceled) 
     
     
         71 . A method of treating a disorder in which TNFα activity is detrimental in a subject, the method comprising administering a liquid pharmaceutical composition comprising a pharmaceutically acceptable carrier and a therapeutically effective amount of adalimumab to the subject such that the disorder is treated,
 wherein the adalimumab is produced in a Chinese Hamster Ovary (CHO) cell expression system; 
 wherein the composition comprises 50 mg/ml of adalimumab; 
 wherein the disorder is selected from the group consisting of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, and juvenile rheumatoid arthritis; and 
 wherein the composition is characterized in that when the composition is assayed in a cathepsin L kinetic assay, a level of cathepsin L activity less than 1.5 RFU/s/mg of adalimumab is observed, wherein the cathepsin L kinetic assay comprises:
 i) diluting the composition 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 Z-leucine-arginine-AMC hydrolysis in the linear range in RFU/s/mg of adalimumab. 
 
 
     
     
         72 . The method of  claim 71 , wherein the pharmaceutical composition is packaged in a pre-filled syringe. 
     
     
         73 . The method of  claim 71 , wherein the pharmaceutical composition is suitable for subcutaneous injection. 
     
     
         74 . The method of  claim 71 , wherein the diluted composition has an adalimumab concentration of 20 μg/ml. 
     
     
         75 . The method of  claim 71 , wherein the diluted composition has an adalimumab concentration of 50 μg/ml. 
     
     
         76 . The method of  claim 71 , wherein step i) of the cathepsin L kinetic assay comprises diluting the composition 600 fold. 
     
     
         77 . The method of  claim 71 , wherein the method further comprises the step of administering a therapeutically effective amount of methotrexate. 
     
     
         78 . The method of  claim 71 , wherein the disorder is rheumatoid arthritis. 
     
     
         79 . The method of  claim 71 , wherein the disorder is Crohn's disease. 
     
     
         80 . The method of  claim 71 , wherein the disorder is ulcerative colitis. 
     
     
         81 . The method of  claim 71 , wherein the disorder is ankylosing spondylitis. 
     
     
         82 . The method of  claim 71 , wherein the disorder is psoriatic arthritis. 
     
     
         83 . The method of  claim 71 , wherein the disorder is psoriasis. 
     
     
         84 . The method of  claim 71 , wherein the disorder is juvenile rheumatoid arthritis. 
     
     
         85 . The method of  claim 71 , wherein the disorder is hidradenitis suppurativa.