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 the sources of a range of complex, heterogeneous, and potentially unsafe impurities, and host cell DNA is among those impurities. The residual host cell DNA may result in tumors or adverse reactions. Besides, if these cells carry viruses or harbor harmful nucleic acid, the residual DNA could be infectious. Some regulatory agencies allow 100 pg or less of residual DNA per dose in biopharmaceuticals.
A sensitive host cell quantitation system should be designed to meet or exceed regulatory requirements, while enabling the high-throughput and cost-effectiveness for the robust clearance study. Creative Biogene offers a variety of q-PCR based residual DNA quantification kits for your research. All of them are easy to use and highly sensitive to confirm the rationality of the purification process and ensure the quality and safety of the final biopharmaceutical products.