| 主权项 |
1. A method for preparing an adalimumab formulation, comprising the step of mixing a liquid composition comprising adalimumab with 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 cathepsin L activity of 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. |
