Improved Clearance Of Host Cell Proteins After Virus Inactivation

Residual host cell proteins remain a critical risk in monoclonal antibody processing with even trace levels affecting product quality and stability. Enzymatically active HCPs such as lipases are of particular concern, as they can co-purify with mAbs and compromise high-concentration formulations, making their effective control essential for robust, scalable processes.

Filtration post-viral inactivation (VI) to remove precipitates is a convenient opportunity to reduce HCPs ahead of polishing chromatography utilizing various media of different charge character including Seitz filter media and an AEX membrane. Balanced against purity considerations is the throughput of the process fluid. In this talk, we consider the process development of the VI filtration step for two distinct feeds through the lens of purity, throughput and cost.