| 赵翔,冯建平,孟淑芳.支原体检查的核酸检测方法及方法学验证的思考[J].中国药事,2018,32(8):1020-1027 |
| 支原体检查的核酸检测方法及方法学验证的思考 |
| Considerations on Mycoplasma Detection by Nucleic Acid Detection Method and the Methodological Validation |
| 投稿时间：2018-07-29 |
| DOI：10.16153/j.1002-7777.2018.08.003 |
| 中文关键词: 支原体核酸检测 CAR-T细胞治疗产品 方法学验证 |
| 英文关键词: community-acquired pneumonia(CAP) pharmacoeconomics Chinese patent medicine costeffectiveness analysis |
| 基金项目:国家科技重大专项"创新生物技术药评价及标准化关键技术研究"（编号2018ZX09101001）；国家科技重大专项"基因治疗溶瘤病毒1类新药的临床前和临床研究"（编号2017ZX090303008） |
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| 中文摘要: |
| 支原体是生物制品的最常见外源因子污染物之一，《中国药典》2015年版收录的两种支原体检测方法虽然可灵敏地检测出活的支原体，但因检测时间较长，对实验室设置及实验室人员的技术均有一定要求，且对一些特定的样本及需要快速放行的样本有一定的局限性，如目前研究热点之一的CAT-T细胞治疗产品的过程或放行检验。因此，越来越多的新兴领域的研发者更倾向于采用支原体污染快速检测方法用于中间品放行检测，甚至作为CAR-T细胞等治疗产品的放行检验的补充或替代方法。由此，也带来了另一个药品监管机构所关注的重要问题安全性，即所用的方法是否具有与经典方法相同的灵敏度可以保证产品的安全性。本文总结了近年来我国生物制品采用药典方法检测的支原体污染的现状，分析了支原体核酸检测（NAT）方法的需求与研究现状以及国内外法规对支原体核酸检测方法使用的态度，简述了国外法规对支原体验证的相关要求，并针对目前我国支原体核酸检测法方法学验证的现状提出解决的思路，以期对我国支原体核酸扩增法检测的研发者及使用者提供借鉴。 |
| 英文摘要: |
| Mycoplasma is one of the most common contaminants in biological products. Although the mycoplasma detection methods contained in the 2015 edition of the Chinese Pharmacopoeia can sensitively detect live mycoplasma, due to the long detection time, the certain requirements for laboratory settings and the skills of laboratory personnel, and certain limitations for some specific samples and samples needed to be released quickly, such as the process or release testing of CAT-T cell therapy products, one of the current research focuses. Consequently, more and more researchers in emerging fields tend to use the rapid mycoplasma detection methods for intermediate release testing, even as supplement or alternative to the release testing of therapeutic products such as CAR-T cells. Meanwhile, this brings about another important safety issue concerned by drug regulatory agency, that is, whether the methods used has the same sensitivity as the classical method to ensure the safety of the products. In this paper, we summarized the current status of mycoplasma contamination of biological products detected by methods contained in the Chinese Pharmacopoeia in recent years, analyzed the needs and research status of mycoplasma nucleic acid detection (NAT) methods, and the attitudes of domestic and abroad regulations on the use of mycoplasma NAT methods, briefly described the relevant requirements of foreign regulations on the verification of mycoplasma, and proposed solutions to the current situation of the methodological validation of mycoplasma NAT methods in China in order to provide references for the developers and users of mycoplasma nucleic acid amplification method for mycoplasma detection in China. |
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