Host Cell Protein management

Bioproduction processes rely on a variety of host cell systems—including bacterial, yeast, mammalian, insect, or plant cells—to synthesize the biotherapeutic protein of interest. However, these systems also produce unintended protein contaminants, known as host cell proteins (HCPs).

HCPs are residual impurities that can adversely affect the quality, efficacy, and safety of the biotherapeutic product. Therefore, a critical component of bioproduction workflows is the effective removal of HCPs to acceptable levels to ensure both patient safety and the therapeutic performance of the drug.

To meet stringent regulatory requirements, HCPs must be monitored and quantified using a validated gold-standard method: the sandwich enzyme-linked immunosorbent assay (ELISA).

Please find here the different HCP kits that CliniSciences offers.