Summary
This technical report outlines the development and characterization of host cell protein (HCP) assays in biopharmaceuticals. It discusses the necessity of quantifying HCPs, which are impurities that can lead to adverse immunogenic reactions, regardless of the production method. Traditional detection methods are deemed insufficient, leading to the adoption of optimized immunoassays, particularly ELISA, as the preferred approach. The document contrasts generic and product-specific assays, emphasizing the importance of antigen selection and the challenges associated with assay development. It details the immunization procedure, which is critical yet unpredictable, and the purification of antibodies from crude serum to enhance assay specificity and sensitivity. The report also describes the calibration of assays and the criteria for system suitability, ensuring accurate detection of HCPs. The findings aim to guide researchers in the early stages of drug development to effectively manage process-related impurities.
