Recovery & Purification
How Low Can We Go; Application of Multimodal Cation Exchange Chromatography for Reduction of HCP and High Molecular Weight Species for Non-IgG Purification
This talk will highlight the use of a multimodal cation exchange (MMCEX) chromatography column as a polishing step to reduce host cell protein (HCP) and high molecular weight species in a non-IgG production process. The reduction of impurities was achieved by influencing the effects of charge and hydrophobic interactions of the MMCEX chromatography. Specifically, buffer and protein load compositions were studied for its capacity to exploit both CEX and HIC components of the resin ligand during product elution. A high throughput robotic screen was first performed to identify key process parameters and minimize the number of lab scale chromatography experiments. Ultimately, the MMCEX column was implemented as the final chromatography unit operation in the non-IgG purification process to reduce HCP levels approximately 10-fold while maintaining process manufacturability and desired product quality.
Zahari Begum -
Senior Ressearch Associate, Pharma Technical Development, Purification Development,