More and more mammalian cells, especially continuous cell lines (CCLs), were used to produce vaccines and therapeutic biological products with the rapid development of biomedical technologies. The doses of recombinant protein products has increased from microgram to milligram or even gram for the demand of clinical treatment, and more biological products needed long-term and repeated administration. Meanwhile, the users of vaccines were healthy people and many vaccines have been used for infants and youth, therefore, more attention should be paid from drug regulatory authorities to the safety of biological products, among which people mainly focused on the quality control of residual DNA all the time. This article systematically reviewed the opinions of residual DNA at home and abroad on different periods, quality control standards and the detecting methods of residual DNA, as well as the effort should be made on residual DNA issues in the future.%随着生物医药技术的飞速发展,越来越多的哺乳动物细胞,尤其是连续传代细胞系用于生产疫苗和治疗性生物制品.重组蛋白制品的用量随着临床治疗效果的需求越来越大,由微克级上升到了毫克甚至克级,需要长期反复用药的生物制品也越来越多.同时疫苗的使用者为健康人群,而且很多疫苗使用人群也扩大到婴幼儿,这使得药品监管部门不得不更加重视疫苗等生物制品的安全性,其中细胞残余DNA的质量控制一直是人们关注的热点.本文就不同时期国内外对于DNA残留问题的看法、DNA残留量质控标准的制定、DNA残留量检测方法等研究进展作一综述,并提出残余DNA问题未来需要进一步开展的工作.
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