Reduce The Level Of Host Cell Protein In The Bioreactor Harvest

Host cell proteins (HCPs) are an inevitable byproduct of biologics manufacturing and can have an impact on product quality and efficacy as well as patient safety. Processes designed to remove HCPs from the bioreactor harvest must not only be successful in achieving acceptable limits, but also be scalable. Our client had one month to reduce the level of HCPs in the bioreactor harvest prior to a production run to supply drug substance for a scheduled Phase 1 clinical trial. The combination of caprylic acid precipitation and Clarisolve® filters enabled a reduction of 80% of harvest HCPs to reach a target of less than 100ppm at the end of process purification and clarification of the entire 2000L harvest.

Learn more from LS Process Validation Expert, Nadia Oueslati, Ph.D. from BioReliance® End-to-End Solutions, MilliporeSigma.