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.
The analytical methods used to determine the residual DNA content of biopharmaceuticals include hybridization based assay, DNA-binding protein based residual DNA assay, quantitative PCR (q-PCR), or other DNA amplification methods. Among these methods, quantitative PCR (q-PCR) is currently the most commonly used technique to determine the content of residual DNA. Creative Biogene offers a variety of q-PCR based residual DNA quantification kit for your research. All of them are easy to use and high sensitivity that can help you to confirm the rationality of the purification process and ensure quality and safety of the final biopharmaceutical products.