A product numbered 410001 has been added to the National Standard Drug Substance List of the China Food and Drug Control Research Institute website: CHO Host Cell DNA Residue Detection Kit (PCR-Fluorescence Probe Method). This kit, jointly developed by the Chinese Inspectorate and the Chinese Academy of Sciences, is synchronized with the current United States Pharmacopoeia (USP) recommended method, but is different from the exogenous DNA residue determination method in the 2010 edition of the Pharmacopoeia Appendix. It may have an impact on upstream and downstream enterprises in the research and development and production of domestic biological products. The residual DNA of host cells in biological products has potential tumorigenic and infectious risks, so the drug regulatory authorities in various countries have strict requirements on the limits of DNA impurities. The US Pharmacopoeia introduces three commonly used techniques in General Chapter <1130>, but will add a new chapter (General Chapter <30>) to the new edition (USP38-NF33) issued in 2015 to further standardize methods and reference materials for residual DNA detection. . Unlike the section above 1000, the USP No. 1000 section specifies the inspection techniques, system suitability standards, and reference materials. The new USP will only recommend the qPCR method as the standard method for host residual DNA in biological products. The technical advantage of the qPCR method is that it has high sequence specificity, high sensitivity and good reproducibility, and can provide a reliable detection method for the biopharmaceutical industry in process research and quality control of finished products. China has long been restricting the amount of residual DNA in biological products with reference to WHO, FDA and EU standards. From the "Quality Control Points for Human Recombinant DNA Products" promulgated by the Ministry of Health to the "Chinese Biological Products Regulations" issued in recent years, the DNA content has been strictly required, and some standards are higher than international standards. The 2010 edition of the Chinese Pharmacopoeia appendix includes the DAN probe hybridization method and the fluorescent dye method. Both of these methods have technical defects, and it is difficult to achieve the sensitivity of the impurity limit detection, which has been abandoned by the European and American Pharmacopoeia. At present, there are still many domestic companies using these two methods to detect residual DNA, which makes it difficult to achieve the world-class level of production technology and product quality. According to the development trend of residual DNA detection technology, Xiaobian expects qPCR method to appear in China's 2015 edition of the pharmacopoeia or supplemental version. In the production and R&D, the enterprise adopts the kits provided in the catalogue of the standard materials of the Chinese inspector, which can greatly reduce the time-consuming, labor-intensive and costly methodological investigation. It only needs to carry out a small number of methods to adapt to the experiment and can be in the production process. And the optimization of the quality control system plays a practical role, while meeting the requirements of the relevant FDA standards. At the same time, the joint research and development unit Huzhou Nutrition Center of the Chinese Academy of Sciences provides free technical advice and training to help enterprises solve various technical problems in the application of kits. Biological products can be used to treat and prevent diseases, and it is related to the safety of medication for patients and healthy people, and product quality must be guaranteed. China's drug regulatory authorities have very strict standards for the determination of residual DNA in biological products, but there are certain lags in the revision of the pharmacopoeia. There is still a gap between the testing technology in the appendix and the advanced countries. Enterprises should have certain forward-looking in research and development and production. Otherwise, efforts to improve the process, improve quality, and ensure safety will be greatly reduced. Nature material Nature Materials,Synthetic Leather,Polyurethane Leather,Pu Faux Leather DONGGUAN SHENGYUAN INDUSTRIAL CO,.LTD. , https://www.elementpuleather.com