Creative Biogene is a leading biotechnology company which has the expertise in providing host cell protein assay services...
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Creative Biogene is a leading biotechnology company which has the expertise in providing host cell protein assay services and related products for customers worldwide. Creative Biogene's sophisticated equipments, advanced technologies and highly experienced staffs are available to perform host cell protein assay by various methods including ELISA, western-blot, 2D gel electrophoresis and MS ect. Creative Biogene’s goal is to provide you with a reliable and accurate host cell protein assay results or related host cell proteim assay kits to ensure your satisfaction in a timely and professional manner.
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 product 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 your research. Either the assay service or the related quantification kits provided by Creative Biogene can help you to confirm the rationality of the purification process and ensure quality and safety of the final biopharmaceutical products.
Advantages of our host cell protein assay services: