Patent ID: 8916153
Filing Date: 2014-12-23
Classification: A61K,A61P,C07K

Abstract:
1. A pharmaceutical composition comprising adalimumab and a pharmaceutically acceptable carrier, wherein the adalimumab is produced in a Chinese Hamster Ovary (CHO) cell expression system; 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 from 0.4 to less than 1.84 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.