Host Cell Proteins (HCPs) are proteins produced or encoded by the host organisms that are used to produce biological products. Biological products, especially therapeutic proteins, are usually produced by genetically modified prokaryotic or eukaryotic cells. During the biological products production, host cells also coproduce proteins related to the normal cell functions such as cell growth, proliferation, survival, gene transcription, protein synthesis, etc. which become a major part of process-related impurities. HCPs are critical to drug safety, efficacy, and regulatory qualification. Incomplete detection in biotherapeutics development can lead to product degradation, product instability, and adverse immunogenic reactions in patients. Therefore, it is a regulatory requirement to monitor the removal of HCPs and assay the residual HCPs in drug products during bioprocess development.
The methods used for identification and/or quantification of HCPs can be classified as either specific methods, such as ELISA and western blot, or non-specific methods, such as electrophoresis and MS. Among these, ELISA, electrophoresis, and MS are the most common techniques and sometimes they are used in combination for detailed characterization. Creative Biogene, as a leading biotechnology company in the world, can offer various methods to detect and assay the amounts of residual host cell proteins, as well as providing a variety of ELISA-based HCPs assay kits for clients' research. Either the assay service or the related quantification kits provided by Creative Biogene can help customers to confirm the rationality of the purification process and ensure the quality and safety of the final biopharmaceutical products.