Inventors:
Min Wan - Cary NC
George Y. Wang - Houston TX
International Classification:
C07K 1600
Abstract:
Disclosed are methods and processes for removing aggregates and other impurities from partially purified protein bulk product, in particular, from partially purified monoclonal antibody, using anion exchange chromatography. In such methods and processes, the pH of the sample is adjusted to be lower than the isoelectric point of the product, preferably by 0. 2 logs, and the sample is passed through an ion exchange matrix which is equilibrated to bind the aggregates and host cell DNA as well as endotoxins in the sample.