Critical Steps to Consider During Customized Host Cell Protein (HCP) ELISA Development

The manufacturing of recombinant drugs requires comprehensive monitoring of process-related impurities, such as HCPs, as they may pose a significant health risk to patients. EMA and FDA approval relies on robust analytical data to prove acceptable HCP clearance. The enzyme-linked immunosorbent assay (ELISA) is the gold standard method for monitoring HCP content during product development and batch release testing within clinical and commercial phases. Supporting data from various orthogonal methods, including 2D Western Blot/2D DIGE analysis and mass spectrometry, should be collected to further complete the analytical puzzle during HCP assay development.

BioGenes is a service provider with many years of experience in the development of customized HCP ELISAs. In this article, our experts – Stefan Sommerschuh (Head of Immunoassay Department) and Pia Paarmann (Head of 2D Analytics) – answer frequently-asked questions and give recommendations for the entire process, from proper mock preparation to antibody performance criteria and reagent characterization by orthogonal methods.