Article(id=1236335231804952900, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, 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=1678636800000, acceptedDateStr=2023-03-13, onlineDate=1772694889259, onlineDateStr=2026-03-05, pubDate=1696003200000, pubDateStr=2023-09-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694889259, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694889259, creator=13701087609, updateTime=1772694889259, updator=13701087609, issue=Issue{id=1236335227262529633, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='18', pageStart='1801', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694888176, creator=13701087609, updateTime=1772694973637, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335585770656362, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335585770656363, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1837, endPage=1842, ext={EN=ArticleExt(id=1236335232052416846, articleId=1236335231804952900, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Review of in vitro potency assays for CAR-T cell therapy products, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

As the use of cell therapy products such as chimeric antigen receptor T cells (CAR-T) is getting matured, there has been an increasing interest in the methods used to test the quality of cell therapy products. In vitro viability assay is an important method for evaluating the effectiveness of cell therapy products and is also widely used in the product release process because of its simplicity and rapidity. In this paper, we review the in vitro potency determination methods for cell therapy products such as CAR-T from the perspective of both effector cells and target cells.

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随着嵌合抗原受体T细胞(chimeric antigen receptor T cell, CAR-T)等细胞治疗产品的应用走向成熟,其产品质量的检测方法也日渐受到关注。体外活力是评价细胞治疗产品有效性的重要方法,体外效力测定方法也以其简单、快速的特点,在产品放行过程中被广泛采用。本文从效应细胞及靶细胞这2个角度对CAR-T等细胞治疗产品体外效力测定方法进行综述。

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邵泓,女,主任药师,研究方向:药物分析。E-mail:
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王自强,男,副主任药师,研究方向:分子生物学。E-mail:

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CAR-T细胞治疗产品体外效力的检测策略与技术进展
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王自强 , 王灿 , 厉高慜 , 段徐华 , 邵泓
中国新药杂志 | 生物医药前沿 2023,32(18): 1837-1842
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中国新药杂志 | 生物医药前沿 2023, 32(18): 1837-1842
CAR-T细胞治疗产品体外效力的检测策略与技术进展
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王自强 , 王灿, 厉高慜, 段徐华, 邵泓
作者信息
  • 上海市食品药品检验研究院/国家药品监督管理局治疗类单抗质量控制重点实验室/上海市创新生物质品质量检验检测中心,上海 201203
  • 王自强,男,副主任药师,研究方向:分子生物学。E-mail:

通讯作者:

邵泓,女,主任药师,研究方向:药物分析。E-mail:
Review of in vitro potency assays for CAR-T cell therapy products
Zi-qiang WANG , Can WANG, Gao-min LI, Xu-hua DUAN, Hong SHAO
Affiliations
  • Shanghai Institute for Food and Drug Control/National Medical Products Administration Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies/Shanghai Quality Inspection and Testing Center for Innovative Biological Products, Shanghai 201203, China
出版时间: 2023-09-30
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随着嵌合抗原受体T细胞(chimeric antigen receptor T cell, CAR-T)等细胞治疗产品的应用走向成熟,其产品质量的检测方法也日渐受到关注。体外活力是评价细胞治疗产品有效性的重要方法,体外效力测定方法也以其简单、快速的特点,在产品放行过程中被广泛采用。本文从效应细胞及靶细胞这2个角度对CAR-T等细胞治疗产品体外效力测定方法进行综述。

CAR-T细胞  /  效力测定  /  质量控制  /  细胞杀伤  /  细胞因子分泌

As the use of cell therapy products such as chimeric antigen receptor T cells (CAR-T) is getting matured, there has been an increasing interest in the methods used to test the quality of cell therapy products. In vitro viability assay is an important method for evaluating the effectiveness of cell therapy products and is also widely used in the product release process because of its simplicity and rapidity. In this paper, we review the in vitro potency determination methods for cell therapy products such as CAR-T from the perspective of both effector cells and target cells.

CAR-T cells  /  potency assay  /  quality control  /  cell killing  /  cytokine secretion
王自强, 王灿, 厉高慜, 段徐华, 邵泓. CAR-T细胞治疗产品体外效力的检测策略与技术进展. 中国新药杂志, 2023 , 32 (18) : 1837 -1842 .
Zi-qiang WANG, Can WANG, Gao-min LI, Xu-hua DUAN, Hong SHAO. Review of in vitro potency assays for CAR-T cell therapy products[J]. Chinese Journal of New Drugs, 2023 , 32 (18) : 1837 -1842 .
2023年第32卷第18期
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  • 首发时间:2026-03-05
  • 出版时间:2023-09-30
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  • 录用日期:2023-03-13
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    上海市食品药品检验研究院/国家药品监督管理局治疗类单抗质量控制重点实验室/上海市创新生物质品质量检验检测中心,上海 201203

通讯作者:

邵泓,女,主任药师,研究方向:药物分析。E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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