Article(id=1236360798252102257, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236360790672986545, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1700668800000, acceptedDateStr=2023-11-23, onlineDate=1772700984775, onlineDateStr=2026-03-05, pubDate=1703865600000, pubDateStr=2023-12-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772700984775, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772700984775, creator=13701087609, updateTime=1772700984775, updator=13701087609, issue=Issue{id=1236360790672986545, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='24', pageStart='2441', pageEnd='2543', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772700982968, creator=13701087609, updateTime=1772701059772, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236361112883622634, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236360790672986545, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236361112883622635, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236360790672986545, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2447, endPage=2451, ext={EN=ArticleExt(id=1236360798470206078, articleId=1236360798252102257, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A brief analysis of the focus of production capacity research of autologous CAR-T therapeutic products, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Autologous chimeric antigen receptor T cell (CAR-T) cell therapy products have brought significant survival benefits to tumor patients, especially in the treatment of hematologic tumors. However, the common production mode of autologous CAR-T therapy products is complicated and has a long cycle. As a result, the production capacity of this kind of products has limited their clinical application to a certain extent. In this paper, based on the analysis of the common production mode of autologous CAR-T cell products, the content and evaluation of the capacity confirmation study and capacity change study of autologous CAR-T therapeutic products are proposed in combination with the current research progress, hoping to effectively promote the development and clinical application of such products.

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自体嵌合抗原受体T细胞（chimeric antigen receptor T cell, CAR-T）治疗产品在肿瘤治疗尤其是血液系统肿瘤治疗方面为患者带来了显著的生存获益，但自体CAR-T类治疗产品常见的生产模式流程复杂、周期较长，造成该类产品的产能在一定程度上限制了其临床应用。本文结合当前研究进展，在针对自体CAR-T细胞产品常见生产模式分析的基础上，提出自体CAR-T类治疗产品产能确认研究和产能变更研究内容与评价考虑，以期能促进此类产品的研发和临床应用。

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王雪，女，审评员， 主要从事生物制品药学研究。联系电话：(010)80996145，E-mail: wangx@cde.org.cn。

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王雪，女，审评员， 主要从事生物制品药学研究。联系电话：(010)80996145，E-mail: wangx@cde.org.cn。

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