Recovery & Purification
Removal of CHO Protein - Phospholipase B-Like 2 (PLBL2) During Downstream Processing of Monoclonal Antibodies
Effective removal of host cell proteins (HCPs) and impurities is necessary during mAb manufacturing produced in Chinese Hamster Ovary (CHO) cells. As such, most HCPs and impurities are cleared by rProtein A affinity chromatography, followed by one or two polishing steps in the standard downstream process. A specific HCP present in the cell culture, phospholipase B-like 2 (PLBL2), has been found to degrade a surfactant present in the drug substance formulation, and therefore, clearance during the downstream process is critical to ensure product stability. However, clearance of PLBL2 presents challenges due to a detectability issue using commercial HCP assay kits. We have studied PLBL2 (lipase enzyme) activities, challenges associated with its removal, and evaluated suitability of polishing chromatography during process development. In this presentation, we will d iscuss s imple ways of addressing clearance of PLBL2 during downstream processing of mAb products.
Mukesh Mayani, Ph.D. -
Scientist II (Process Development), Biologics Process Development,