Progress towards global standardization for quantitative flow cytometry

图书馆学 标准化 计算机科学 操作系统
作者
Christèle Gonneau,Lili Wang,Shibani Mitra‐Kaushik,Paul C. Trampont,Virginia Litwin
出处
期刊:Bioanalysis [Newlands Press Ltd]
卷期号:13 (21): 1591-1595 被引量:5
标识
DOI:10.4155/bio-2021-0148
摘要

BioanalysisVol. 13, No. 21 CommentaryProgress towards global standardization for quantitative flow cytometryChristèle Gonneau, Lili Wang, Shibani Mitra-Kaushik, Paul C Trampont & Virginia LitwinChristèle GonneauCentral Laboratory Services, Labcorp Drug Development, 1217 Meyrin, Geneva, SwitzerlandSearch for more papers by this author, Lili WangBiosystems & Biomaterials Division, National Institute of Standards & Technology (NIST), Gaithersburg, MD 20899, USASearch for more papers by this author, Shibani Mitra-Kaushik https://orcid.org/0000-0002-9119-0393Bioanalytics-Genomic Medicine Unit, Sanofi, Framingham, MA 01701, USASearch for more papers by this author, Paul C TrampontNexelis, Seattle, WA 98119, USA (currently at Moderna Inc., Norwood, MA 02062, USA)Search for more papers by this author & Virginia Litwin*Author for correspondence: Tel.: +1 514 709 2858; E-mail Address: Virginiam.litwin@gmail.comCaprion Biosciences, QC, H2X 3Y7, CanadaSearch for more papers by this authorPublished Online:16 Sep 2021https://doi.org/10.4155/bio-2021-0148AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: cell and gene therapyCLSI H62flow cytometryNIST consortiumstandardsvalidationReferences1. CLSI. Validation of Assays Performed by Flow Cytometry. CLSI document H62. 1st Edition Wayne PA (Ed.). Clinical Laboratory Standards Institute (2021).Google Scholar2. Litwin V, Wallace P, Green C. Issue highlights. Cytometry B Clin. Cytom. 100(1), 7–9 (2021).Crossref, Google Scholar3. O'hara DM, Xu Y, Liang Z, Reddy MP, Wu DY, Litwin V. Recommendations for the validation of flow cytometric testing during drug development: II assays. J. Immunol. Methods 363(2), 120–134 (2011).Crossref, Medline, Google Scholar4. Wood B, Jevremovic D, Bene MC et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS – part V – assay performance criteria. Cytometry B Clin. Cytom. 84(5), 315–323 (2013).Crossref, Medline, Google Scholar5. Czechowska K, Lannigan J, Wang L et al. Cyt‐Geist: current and future challenges in cytometry: reports of the CYTO 2018 conference workshops. Cytometry A 95(6), 598–644 (2019).Crossref, Medline, Google Scholar6. 21 CFR 820.30. Food and Drug Administration, Department of Health and Human Services Subchapter H–Medical Devices, Part 820 Quality System Regulation. Code of Federal Regulations, US Government Publishing Office, USA (2019). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.3Google Scholar7. ISO. Medical devices– quality management systems – requirements for regulatory purposes. European Committee for Standarization EN ISO 13485 section 7.3 design and development. International Organization for Standardization, Geneva, Switzerland (2016). https://www.iso.org/iso-13485-medical-devices.htmlGoogle Scholar8. ISO. Guidelines for auditing management systems. European Committee for Standardization EN ISO 9001. International Organization for Standardization, Geneva, Switzerland (2015). https://www.iso.org/standard/62085.htmlGoogle Scholar9. Hilt E, Sun YS, Mccloskey TW et al. Best practices for optimization and validation of flow cytometry-based receptor occupancy assays. Cytometry B Clin. Cytom. 100(1), 63–71 (2021).Crossref, Medline, Google Scholar10. Sarikonda G, Mathieu M, Natalia M et al. Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses. Cytometry B Clin. Cytom. 100(1), 79–91 (2021).Crossref, Medline, Google Scholar11. Sommer U, Eck S, Marszalek L et al. High-sensitivity flow cytometric assays: considerations for design control and analytical validation for identification of rare events. Cytometry B Clin. Cytom. 100(1), 42–51 (2021).Crossref, Medline, Google Scholar12. Cabanski M, Oldaker T, Stewart JJ et al. Flow cytometric method transfer: recommendations for best practice. Cytometry B Clin. Cytom. 100(1), 52–62 (2021).Crossref, Medline, Google Scholar13. Sanjabi S, Lear S. New cytometry tools for immune monitoring during cancer immunotherapy. Cytometry B Clin. Cytom. 100(1), 10–18 (2021).Crossref, Medline, CAS, Google Scholar14. Saksena S, Chattopadhyay P. Illuminating the immunopathology of SARS-CoV-2. Cytometry B Clin. Cytom. 100(1), 33–41 (2021).Crossref, Medline, CAS, Google Scholar15. NIST Flow Cytometry Standards Consortium. https://www.nist.gov/programs-projects/nist-flow-cytometry-standards-consortiumGoogle Scholar16. Advanced therapies laboratory programs. https://www.nist.gov/programs-projects/advanced-therapies-laboratory-programsGoogle Scholar17. Green CL, Brown L, Stewart JJ, Xu Y, Litwin V, Mc Closkey TW. Recommendations for the validation of flow cytometric testing during drug development: i instrumentation. J. Immunol. Methods 363(2), 104–119 (2011).Crossref, Medline, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByDemands and technical developments of clinical flow cytometry with emphasis in quantitative, spectral, and imaging capabilitiesNanotechnology and Precision Engineering, Vol. 5, No. 4Quantitative flow cytometry leveraging droplet‐based constriction microchannels with high reliability and high sensitivity23 November 2022 | Cytometry Part A, Vol. 37Special Focus Issue - Performing flow cytometry in clinical trialsHenko Tadema8 November 2021 | Bioanalysis, Vol. 13, No. 21The Evolution of Single-Cell Analysis and Utility in Drug Development13 August 2021 | The AAPS Journal, Vol. 23, No. 5 Vol. 13, No. 21 Follow us on social media for the latest updates Metrics Downloaded 287 times History Received 2 July 2021 Accepted 6 September 2021 Published online 16 September 2021 Published in print November 2021 Information© 2021 Newlands PressKeywordscell and gene therapyCLSI H62flow cytometryNIST consortiumstandardsvalidationAcknowledgmentsC Gonneau, L Wang, S Mitra-Kaushik, PC Trampont and V Litwin made substantial contributions to the content of this manuscript.Financial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
anthea完成签到 ,获得积分10
刚刚
量子星尘发布了新的文献求助10
1秒前
2秒前
月皎完成签到 ,获得积分10
3秒前
iris2333发布了新的文献求助10
4秒前
烟花应助wzz采纳,获得10
4秒前
小凯完成签到,获得积分10
4秒前
狂野风华完成签到 ,获得积分10
4秒前
布丁完成签到,获得积分10
5秒前
美好斓发布了新的文献求助30
5秒前
humorlife完成签到,获得积分10
6秒前
selean完成签到,获得积分10
6秒前
7秒前
一玮完成签到 ,获得积分10
8秒前
垃圾桶完成签到 ,获得积分10
8秒前
福多多完成签到 ,获得积分10
9秒前
小蘑菇应助酷炫的__采纳,获得10
10秒前
hydrogen完成签到,获得积分10
10秒前
大模型应助神经蛙采纳,获得10
11秒前
凡夫俗子完成签到,获得积分10
11秒前
F_ken发布了新的文献求助10
12秒前
Jasper应助无私采白采纳,获得10
13秒前
拼搏冬瓜完成签到 ,获得积分10
14秒前
14秒前
和谐白云完成签到,获得积分10
18秒前
19秒前
19秒前
小小发布了新的文献求助30
20秒前
超级日光完成签到 ,获得积分20
21秒前
Rainsoul完成签到 ,获得积分10
22秒前
22秒前
23秒前
24秒前
lf完成签到,获得积分10
24秒前
zict2010发布了新的文献求助10
24秒前
上善若水呦完成签到 ,获得积分10
24秒前
一一发布了新的文献求助10
25秒前
滴滴答答完成签到,获得积分10
25秒前
wzz发布了新的文献求助10
27秒前
27秒前
高分求助中
(应助此贴封号)【重要!!请各用户(尤其是新用户)详细阅读】【科研通的精品贴汇总】 10000
List of 1,091 Public Pension Profiles by Region 1581
以液相層析串聯質譜法分析糖漿產品中活性雙羰基化合物 / 吳瑋元[撰] = Analysis of reactive dicarbonyl species in syrup products by LC-MS/MS / Wei-Yuan Wu 1000
Biology of the Reptilia. Volume 21. Morphology I. The Skull and Appendicular Locomotor Apparatus of Lepidosauria 600
The Scope of Slavic Aspect 600
Foregrounding Marking Shift in Sundanese Written Narrative Segments 600
Rousseau, le chemin de ronde 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 纳米技术 计算机科学 内科学 化学工程 复合材料 物理化学 基因 遗传学 催化作用 冶金 量子力学 光电子学
热门帖子
关注 科研通微信公众号,转发送积分 5539792
求助须知:如何正确求助?哪些是违规求助? 4626553
关于积分的说明 14599759
捐赠科研通 4567423
什么是DOI,文献DOI怎么找? 2504037
邀请新用户注册赠送积分活动 1481750
关于科研通互助平台的介绍 1453372