Article(id=1291404706874646986, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404681641713991, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.07.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1730217600000, receivedDateStr=2024-10-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824475258, onlineDateStr=2026-08-04, pubDate=1744819200000, pubDateStr=2025-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824475258, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824475258, creator=13701087609, updateTime=1785824475258, updator=13701087609, issue=Issue{id=1291404681641713991, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1744819200000', pubDateStr='2025-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824469242, creator='13701087609', updateTime=1785824469242, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1013, endPage=1019, ext={EN=ArticleExt(id=1291404707088556491, articleId=1291404706874646986, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Detection and analysis of genome integration sites in cell and gene therapy product evaluation, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=

Whether in vivo gene therapy products or in vitro gene-modified cell therapy products, the risk of gene insertion and mutation of integration in the gene modification safety evaluation are all key contents of concern. With the development of high-throughput sequencing and bioinformatics analysis technology, integrated site detection and analysis have been able to provide important information for understanding and judging risk. However, the safety prediction has not been achieved ideally. One of the core challenges is the methodological development of integration sites detection. On the one hand, it is the technical limitation of the assays, on the other hand, there is no public technical standard for the assays. In this paper, the commercial integration site detection technologies in safety evaluation of cell and gene therapy products are introduced. The challenges and future solutions are also discussed.

, authors=Zhen-dong LI¹, Zhen-peng ZHONG¹, Feng-qing DONG¹, Mei-ting LIAN¹, Xiang-xiang PENG¹, Guo-zhen ZHU¹, Yi-fei CHEN^2a, Gang LI^2b, Qi-kuan HUANG¹, authorsList=Zhen-dong LI, Zhen-peng ZHONG, Feng-qing DONG, Mei-ting LIAN, Xiang-xiang PENG, Guo-zhen ZHU, Yi-fei CHEN, Gang LI, Qi-kuan HUANG, authorCompany=null, correspAuthors=Qi-kuan HUANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404707432489420, articleId=1291404706874646986, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=细胞与基因治疗产品评价中的基因组整合位点检测与分析, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=

无论是体内基因治疗产品还是经体外基因修饰的细胞治疗产品，基因修饰后的安全性评价中基因插入风险以及整合后突变风险都是关键的关注内容。随着高通量测序与生物信息学分析技术的发展，整合位点检测与注释分析已可以为理解和判断风险提供重要的数据信息，但尚未实现理想预测体内治疗安全性的水平。其中的核心挑战之一即是对基因组整合位点的方法学开发，一方面是分析手段自身的技术限制，另一方面是整合位点分析的技术规范尚无公认标准。本文分析了细胞与基因治疗产品安全性评价中的整合位点检测现状与商业化常用技术，讨论了现有挑战与未来的解决策略。

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李振东（1990-），男，主管技师，主要从事药物生物分析工作

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李振东（1990-），男，主管技师，主要从事药物生物分析工作

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