HCP Antibody Coverage in Biopharma Quality Control
When it comes to biopharmaceutical manufacturing, ensuring the highest level of quality control is non-negotiable. Host Cell Protein (HCP) contamination remains a major challenge in drug development, making HCP antibody coverage a crucial aspect of biopharma quality assurance. Without effective detection and quantification of residual HCPs, the safety, efficacy, and regulatory approval of biologics could be compromised. This article explores the significance of HCP antibody coverage, the challenges in achieving comprehensive detection, and best practices for optimizing biopharma quality control. Why HCP Antibody Coverage Matters in Biopharma During biopharmaceutical production, host cells, such as E. coli, CHO cells, or yeast, are commonly used to express therapeutic proteins. However, along with the target biologic, these host cells also produce unintended proteins—HCPs—that can remain in the final drug product. Even at trace levels, HCPs pose risks such as immunogenicity, re...