Performance Of 3M™ Emphaze™ AEX Hybrid Purifier In Monoclonal Antibody (mAb) Purification Process In Mammalian Cell Cultures

By Himanshu Nivsarkar, Alexei Voloshin, Jonathan F. Hester, Angelines Castro Forero and Gregory M. Jellum, 3M Separation and Purification Sciences Division

The 3M Emphaze AEX Hybrid Purifier is designed to reduce DNA, HCP, endotoxin, and cell debris. It is typically positioned as the second stage of clarification after the primary cell capture step (for example, Centrifugation or Depth Filtration). The 3M Emphaze AEX Hybrid Purifier delivers consistent, high purity clarified fluid to the capture chromatography operation. The reduction of DNA, HCP, and cell debris early in the purification process may confer benefits across the protein A column, such as higher product purity in the protein A eluate, and reduced turbidity of the neutralized viral inactivation pool.

In this tech note, we describe the performance and benefits of the 3M Emphaze AEX Hybrid Purifier in a typical monoclonal antibody purification process. We evaluate the performance in terms of turbidity reduction, HCP reduction, and DNA reduction at clarification, and its effect on protein A column purification performance.