host cell protein analysis

Host cell proteins (HCPs) are a heterogeneous mixture of proteins carried over from the host expression system, and the main impurities in the process of bio-therapeutic manufacturing. The HCPs, either secreted proteins or intracellular proteins released during cell lysis, might influence the enzymatic modification and stability of products, cause failure of a certain purification step, and induce immunogenicity or decreasing activity, etc. FDA and EMA has set the acceptable limits of HCPs, but unknown HCPs at a low level might still leads to an immunogenic effect. To ensure safety and potency of biopharmaceutical products during drug discovery, detection and elimination of HCPs during bio-therapeutics purification are important and required.