摘要 |
<p>A process for monitoring the effectiveness of a purification process in removing plasminogen activator (PA) endogenous to Chinese hamster ovary (CHO) cells from a sample containing human tPA. Process involves incubating a sample with a Arg275-Ile276 (of human wild type tPA) bond-cleaving protease and then a denaturing agent and a reducing agent, then subjecting the sample to reversed-phase high performance liquid chromatography. The resultant elution profile is analyzed for the amount present of PA endogenous to the CHO cells.</p> |