Article(id=1322906841440727228, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, 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=1632240000000, acceptedDateStr=2021-09-22, onlineDate=1793335169419, onlineDateStr=2026-10-30, pubDate=1635523200000, pubDateStr=2021-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335169419, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335169419, creator=13701087609, updateTime=1793335169419, updator=13701087609, issue=Issue{id=1322906824709648449, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='20', pageStart='1825', pageEnd='1920', issueExtLink='null', onlineDate='null', pubDate='1635523200000', pubDateStr='2021-10-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793335165428, creator='13701087609', updateTime=1793337419278, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916278284976934, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916278284976935, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1850, endPage=1854, ext={EN=ArticleExt(id=1322906841621082301, articleId=1322906841440727228, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Infection titer detection of Sendai virus vector by flow cytometry, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To establish a rapid, convenient and robust method for detecting the infection titer of Sendai virus (Sev) vectors.

Methods:

With transmission-defective Sendai virus vector as the research target and flow cytometry as the detection method, a mathematic model based on Poisson's distribution was established, and the infection titer was determined by one parameter of the mathematic model after curve-fitting.

Results:

An innovative method for detecting the infection titer of Sendai virus vector was successfully established. There were no significant differences between the results obtained from the flow cytometry method and traditional immunofluorescence method, and the flow cytometry method displayed good reproducibility [infection titer is (2.13±0.05)×109 IU·mL-1, RSD is 2.34%].

Conclusion:

The infection titer detection is an important quality control item of viral vector gene therapy products and the traditional methods such as plaque method, TCID50 method and immunofluorescence method have the disadvantages of long experiment cycle, bad reproducibility and poor objectivity. This study is of significance to be a representative quality control reference for infection titer detecting of other viral vectors.

, authors=Zhi-hao FU, Jun-zhi WANG, authorsList=Zhi-hao FU, Jun-zhi WANG, authorCompany=null, correspAuthors=Jun-zhi WANG, 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=1322906841985986750, articleId=1322906841440727228, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=应用流式细胞术检测仙台病毒载体感染滴度, columnId=1236330552693944345, journalTitle=中国新药杂志, columnName=生物医药前沿, runingTitle=null, highlight=null, articleAbstract=
目的:

建立一种快速、简便和稳健的用于检测仙台病毒载体感染滴度的方法。

方法:

以传播缺陷型仙台病毒载体为研究对象,流式细胞术为检测方法,建立以泊松分布为基础的数学模型做曲线拟合,以函数中的一项参数做感染滴度的结果判定。

结果:

成功建立了流式细胞术检测仙台病毒载体感染滴度的新方法。与传统的免疫荧光法比较,检测结果无显著性差异,且新方法具有更好的重现性,感染滴度为(2.13±0.05)×109 IU·mL-1,相对标准偏差(RSD)为2.34%。

结论:

病毒载体类基因治疗产品的感染滴度是该类制品的一项重要质控指标。传统的测定方法,如噬斑法、组织半数感染量(TCID50)法和免疫荧光法,实验周期长、重现性差,而且结果判定受主观因素影响。本研究建立了一种适合传播缺陷型仙台病毒载体感染滴度测定的新方法,也可为其他类型病毒载体感染滴度的测定方法研究提供参考。

, authors=付志浩, 王军志, authorsList=付志浩, 王军志, authorCompany=null, correspAuthors=王军志, authorNote=

付志浩,男,副研究员,主要从事生物技术药质量控制研究。E-mail:。

, correspAuthorsNote=
王军志,男,研究员,主要从事生物制品质量评价研究。E-mail:。
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付志浩,男,副研究员,主要从事生物技术药质量控制研究。E-mail:。

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付志浩,男,副研究员,主要从事生物技术药质量控制研究。E-mail:。

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应用流式细胞术检测仙台病毒载体感染滴度
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付志浩 , 王军志
中国新药杂志 | 生物医药前沿 2021,30(20): 1850-1854
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中国新药杂志 |生物医药前沿 2021 , 30 (20) : 1850 -1854
应用流式细胞术检测仙台病毒载体感染滴度
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付志浩,男,副研究员,主要从事生物技术药质量控制研究。E-mail:。

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付志浩 , 王军志
作者信息
  • 中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京 102629
通讯作者:
王军志,男,研究员,主要从事生物制品质量评价研究。E-mail:。
作者简介:

付志浩,男,副研究员,主要从事生物技术药质量控制研究。E-mail:。

Infection titer detection of Sendai virus vector by flow cytometry
Zhi-hao FU , Jun-zhi WANG
Affiliations
  • Division of Monoclonal Antibodies, National Institutes for Food and Drug Control; Key Laboratory of National Health Commission of the PRC for Research on Quality and Standardization of Biotech Products, Beijing 102629, China
出版时间: 2021-10-30
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目的:

建立一种快速、简便和稳健的用于检测仙台病毒载体感染滴度的方法。

方法:

以传播缺陷型仙台病毒载体为研究对象,流式细胞术为检测方法,建立以泊松分布为基础的数学模型做曲线拟合,以函数中的一项参数做感染滴度的结果判定。

结果:

成功建立了流式细胞术检测仙台病毒载体感染滴度的新方法。与传统的免疫荧光法比较,检测结果无显著性差异,且新方法具有更好的重现性,感染滴度为(2.13±0.05)×109 IU·mL-1,相对标准偏差(RSD)为2.34%。

结论:

病毒载体类基因治疗产品的感染滴度是该类制品的一项重要质控指标。传统的测定方法,如噬斑法、组织半数感染量(TCID50)法和免疫荧光法,实验周期长、重现性差,而且结果判定受主观因素影响。本研究建立了一种适合传播缺陷型仙台病毒载体感染滴度测定的新方法,也可为其他类型病毒载体感染滴度的测定方法研究提供参考。

流式细胞术  /  仙台病毒载体  /  感染滴度  /  泊松分布
Objective:

To establish a rapid, convenient and robust method for detecting the infection titer of Sendai virus (Sev) vectors.

Methods:

With transmission-defective Sendai virus vector as the research target and flow cytometry as the detection method, a mathematic model based on Poisson's distribution was established, and the infection titer was determined by one parameter of the mathematic model after curve-fitting.

Results:

An innovative method for detecting the infection titer of Sendai virus vector was successfully established. There were no significant differences between the results obtained from the flow cytometry method and traditional immunofluorescence method, and the flow cytometry method displayed good reproducibility [infection titer is (2.13±0.05)×109 IU·mL-1, RSD is 2.34%].

Conclusion:

The infection titer detection is an important quality control item of viral vector gene therapy products and the traditional methods such as plaque method, TCID50 method and immunofluorescence method have the disadvantages of long experiment cycle, bad reproducibility and poor objectivity. This study is of significance to be a representative quality control reference for infection titer detecting of other viral vectors.

flow cytometry  /  sendai virus vector  /  infection titer  /  Poisson's distribution
付志浩, 王军志. 应用流式细胞术检测仙台病毒载体感染滴度. 中国新药杂志, 2021 , 30 (20) : 1850 -1854 .
Zhi-hao FU, Jun-zhi WANG. Infection titer detection of Sendai virus vector by flow cytometry[J]. Chinese Journal of New Drugs, 2021 , 30 (20) : 1850 -1854 .

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2021年第30卷第20期
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  • 首发时间:2026-10-30
  • 出版时间:2021-10-30
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  • 录用日期:2021-09-22
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    中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京 102629

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王军志,男,研究员,主要从事生物制品质量评价研究。E-mail:。
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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
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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