Host Cell Protein (HCP) monitoring during biological drug manufacturing is crucial. This is required to reduce the adverse side effects that the (high) abundance of host cell protein-derived impurities in the final drug substance may have when administered to human bodies, or when HCP affect the drug product itself. The particular HCP profile of a drug production is unique and depends on particular cell culturing conditions and the quality of manufacturing and downstream processes.

BioGenes has a twenty-year proven track record in the development of highly sensitive Host Cell Protein ELISAs. During this time, we have developed more than 200 HCP ELISAs, which are both multi-product/platform and specific. We are familiar with the requirements of the regulatory bodies, as many of our HCP ELISAs have been used for late stage clinical trials and for drug approvals by the EMA and FDA. To learn from our experience in this field we can now offer you a brand new webinar on demand: Strategies for Successful Host Cell Protein Monitoring.

In this webinar, Charlotte Coenders, Business Development Manager at BioGenes, will showcase BioGenes' approach to HCP monitoring. 

Her presentation will show you why a sophisticated ELISA development strategy supported by orthogonal methods for reagent characterization is essential for a robust and reproducible ELISA-based monitoring of HCP impurities.

This talk was first held at the Bioprocessing Summit 2022 in Boston.