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Creative Biogene is one of the leading biotechnology companies which has the expertise in providing residual DNA testing services and related products for customers worldwide. Creative Biogene's sophisticated equipments, advanced technologies and highly experienced staffs are available to perform residual DNA testing on a wide range of samples including monoclonal antibodies, recombinant protein and viral products produced in cell culture. Creative Biogene's goal is to provide you with a reliable and accurate residual DNA result or related residual DNA quantification kits to ensure your satisfaction in a timely and professional manner.
Biopharmaceutical products, such as therapeutic proteins and vaccines, are produced by fermentation using either bacterial or eukaryotic cells. The cells used to produce biopharmaceuticals can be sources of a range of complex, heterogeneous, and potentially unsafe impurities, and host cell DNA is among these. The residual host cell DNA may result in tumors or adverse reactions. Besides, cells used to produce biopharmaceuticals may possibly carry viruses or harbor harmful nucleic acid, and the residual DNA in a given biopharmaceutical product may be infectious. Therefore, some regulatory agencies have allowed a target of 100 pg or less of residual DNA per dose in biopharmaceuticals, and levels up to 10 ng of residual DNA per dose may be considered, depending on the source of the residual DNA and the product's route.
Currently, the most commonly used method of detecting and quantitating residual DNA is quantitative PCR (qPCR). Creative Biogene, as a leading biotechnology company in the world, can offer highly sensitive methods to detect and quantify minute amounts of residual host cell DNA, as well as providing a variety of q-PCR based residual DNA quantification kit for your research. Either the testing 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 residual DNA testing services:
Creative Biogene specializes in Residual DNA Testing services for a diverse array of host cells, including but not limited to human cells, HEK293, CHO, Vero, NS0, MDCK, E. coli, and Pichia pastoris. Additionally, we offer custom assay development services for unique or specialized host cells. Our expertise ensures precise, reliable results tailored to meet the specific requirements of your unique cell line, enabling advanced research and development in biotechnology and pharmaceutical applications. Partner with Creative Biogene for customized solutions that cater to the nuanced demands of your special host cells.
Residual DNA Quantification Kits at Creative Biogene
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