Briefly on the development trend of residual DNA detection technology and standards in biological preparations

A new product, numbered 410001, has been listed on the National Standard Drug Substance List of the China Food and Drug Control Research Institute website: the CHO Host Cell DNA Residue Detection Kit (PCR-Fluorescence Probe Method). Developed jointly by the Chinese Inspectorate and the Chinese Academy of Sciences, this kit aligns with the current USP-recommended method but differs from the exogenous DNA residue detection approach in the 2010 edition of the Chinese Pharmacopoeia. This development could significantly impact domestic biopharmaceutical companies involved in R&D and production. Residual host cell DNA in biological products poses potential risks such as tumorigenicity and infection, which is why regulatory agencies worldwide impose strict limits on DNA impurities. The USP outlines three commonly used techniques in General Chapter <1130>, but in the 2015 edition (USP38-NF33), a new chapter (<30>) was introduced to further standardize detection methods and reference materials. Unlike previous versions, the updated USP recommends qPCR as the standard method for detecting residual DNA in biological products. The qPCR technique offers high sequence specificity, sensitivity, and reproducibility, making it a reliable tool for process research and quality control in the biopharmaceutical industry. China has long followed international standards set by WHO, FDA, and the EU when regulating residual DNA levels in biological products. From the "Quality Control Points for Human Recombinant DNA Products" issued by the Ministry of Health to the recent "Chinese Biological Products Regulations," DNA content has been strictly controlled, with some standards even exceeding international benchmarks. However, the 2010 edition of the Chinese Pharmacopoeia still included outdated methods like the DNA probe hybridization and fluorescent dye techniques, which are no longer used in Europe or the U.S. due to their limited sensitivity. Many domestic companies continue to use these older methods, hindering their ability to reach global quality standards. Looking ahead, it's expected that the qPCR method will be included in the 2015 edition or a supplement of the Chinese Pharmacopoeia. By adopting kits approved by the Chinese Inspectorate, companies can save time, effort, and costs in method development. A small number of method adaptations are sufficient for implementation in production and quality control systems, while also meeting FDA requirements. Additionally, the Huzhou Nutrition Center, a joint research unit of the Chinese Academy of Sciences, offers free technical support and training to help enterprises overcome challenges in kit application. Biological products play a crucial role in disease treatment and prevention, directly affecting patient safety. Ensuring product quality is essential. While China’s regulatory authorities maintain strict standards for residual DNA testing, there is a lag in updating pharmacopoeia guidelines. There remains a gap between China’s current testing methods and those of advanced countries. Companies must stay ahead in R&D and production; otherwise, efforts to improve processes, ensure safety, and enhance product quality may fall short.

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