Host cell proteins (HCP) are cell-culture related impurities that are incredibly difficult to remove from cell lysates during the biotherapeutic manufacturing process. When present in biotherapeutics, such as monoclonal antibodies, therapeutic proteins, and vaccines, these contaminating proteins can induce adverse reactions. Therefore, scientists must carefully optimize every drug’s purification process and use orthogonal assays to confirm complete HCP removal in the final product.
Download this guide from Cytiva to learn how to optimize HCP assays for challenging biotherapeutic production processes.