Having an appropriate assay to detect host cell proteins (HCPs) is critical in biopharmaceutical development, including the development of gene therapy products. To ensure accurate quantitation of HCPs during the bioproduction process, process- or platform-specific HCP assays are preferred over generic assays. In this session, the development of custom reagents for process-specific HCP ligand-binding assays is described, as well as the development of custom HCP assays on two different platforms (ELISA and Gyrolab immunoassay platform) for product release and in-process support.
