The Development of a Flow-Through Mode Cation Exchange Process for the Purification of a Monoclonal Antibody

by Rachel B. Wollacott, PhD, Lauren E. Roth, PhD, Tracy L. Sears, Rebecca A. Sharpe, Monica Jiang, and Sadettin S. Ozturk, PhD
Volume 14, Issue 2 (Summer 2015)

Cation exchange chromatography is typically utilized in bind-and-elute mode for monoclonal antibody purification. However, during purification process development for a novel monoclonal antibody (MAb) intended for clinical use, it was determined that bind-and-elute conditions were not sufficient for removing significant levels of antibody aggregate. Based on preliminary purification data, an alternative purification method, operation of the cation exchange process in flow-through mode, was investigated. Flow-through mode cation exchange conditions were optimized by design of experiments. Optimal conditions resulted in <1% dimer and >85% recovery at all scales evaluated. An additional anion exchange polishing step was required to remove residual process impurities. The possibility of using the flow-through mode, cation exchange approach as a platform process, as well as the benefits and drawbacks of operating the cation exchange process in flow-through mode for MAb purification are discussed...

Wollacott RB, Roth LE, Sears TL, Sharpe RA, Jiang M, Ozturk SS. The development of a flow-through mode cation exchange process for the purification of a monoclonal antibody. BioProcess J, 2015; 14(2): 5–13.

Posted online July 10, 2015.