Reducing The Level Of Host Cell Proteins 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. A customer 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 high level of HCPs (1,000,000 in the harvest and 700 ppm at the end of purification) unfavorably impacted the planned clarification process and subsequent downstream steps. The goal was to reduce the level of HCPs to a maximum of 300 ppm at the end of process purification and ensure clarification of the entire 2,000 L harvest.

Processes designed to remove HCPs from the bioreactor harvest must be both successful in achieving acceptable limits and scalable. Discover how MilliporeSigma 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 2,000 L harvest.