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

A new product, numbered 410001, has been added to the National Standard Drug Substance List on the website of the China Food and Drug Control Research Institute: the CHO Host Cell DNA Residue Detection Kit (PCR-Fluorescence Probe Method). This kit was jointly developed by the Chinese Inspectorate and the Chinese Academy of Sciences. It aligns with the current USP-recommended method but differs from the exogenous DNA residue detection method in the 2010 edition of the Chinese Pharmacopoeia. Its introduction may influence upstream and downstream enterprises involved in the R&D and production of domestic biological products. Residual host cell DNA in biologics poses potential tumorigenic and infectious risks, which is why regulatory authorities worldwide impose strict limits on DNA impurities. The USP outlines three common techniques in General Chapter <1130>, but the 2015 edition (USP38-NF33) introduced a new chapter, General Chapter <30>, to further standardize methods and reference materials for residual DNA detection. Unlike previous chapters, this new one 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 choice for process research and quality control in the biopharmaceutical industry. China has long followed international standards such as those from WHO, FDA, and EU when setting limits for residual DNA 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 regulated, with some standards even exceeding international levels. However, the 2010 edition of the Chinese Pharmacopoeia still included the DNA probe hybridization and fluorescent dye methods—techniques that have since been phased out by European and American pharmacopoeias due to their limitations in sensitivity and reliability. Many domestic companies continue to use these outdated methods, hindering their ability to reach global production and quality benchmarks. According to the development trends in residual DNA detection technology, it is expected that the qPCR method will be included in the 2015 edition or a supplement of the Chinese Pharmacopoeia. By adopting kits listed in the standard material catalog of the Chinese Inspectorate, companies can significantly reduce the time, effort, and cost associated with method development. A small number of method adaptations will suffice for experimental validation and integration into the production process, ultimately supporting the optimization of quality control systems while meeting FDA requirements. Additionally, the Huzhou Nutrition Center of the Chinese Academy of Sciences, a joint research partner, offers free technical advice and training to help enterprises overcome challenges in applying these kits. Biological products play a critical role in treating and preventing diseases, directly impacting patient safety. Ensuring product quality is essential. While China’s drug regulatory authorities maintain strict standards for residual DNA testing, there is a lag in updating pharmacopoeia guidelines. There remains a gap between the testing technologies in the appendix and those used in advanced countries. Enterprises must stay ahead in R&D and production; otherwise, efforts to improve processes, enhance quality, and ensure safety could be significantly undermined.

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