清晨好,您是今天最早来到科研通的研友!由于当前在线用户较少,发布求助请尽量完整地填写文献信息,科研通机器人24小时在线,伴您科研之路漫漫前行!

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 [Future Science 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
最长约 10秒,即可获得该文献文件

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
8秒前
21秒前
zijingsy完成签到 ,获得积分10
26秒前
kyle完成签到 ,获得积分10
45秒前
1分钟前
LioXH完成签到,获得积分10
1分钟前
量子星尘发布了新的文献求助10
1分钟前
1分钟前
1分钟前
LioXH发布了新的文献求助10
1分钟前
ChatGPT完成签到,获得积分10
1分钟前
1分钟前
大水完成签到 ,获得积分10
1分钟前
Ray完成签到 ,获得积分10
1分钟前
舒适以松发布了新的文献求助10
1分钟前
1分钟前
自然代亦完成签到 ,获得积分10
1分钟前
1分钟前
Yjj发布了新的文献求助20
1分钟前
坤坤完成签到 ,获得积分10
1分钟前
oleskarabach发布了新的文献求助10
1分钟前
外向的芒果完成签到 ,获得积分10
2分钟前
2分钟前
Lexi完成签到 ,获得积分10
2分钟前
量子星尘发布了新的文献求助10
2分钟前
2分钟前
行走完成签到,获得积分10
2分钟前
gwbk完成签到,获得积分10
2分钟前
oleskarabach发布了新的文献求助10
2分钟前
小蘑菇应助Yjj采纳,获得10
2分钟前
2分钟前
SciGPT应助卡卡采纳,获得10
2分钟前
科研通AI2S应助科研通管家采纳,获得10
2分钟前
2分钟前
卡卡发布了新的文献求助10
2分钟前
oleskarabach发布了新的文献求助10
3分钟前
蝎子莱莱xth完成签到,获得积分10
3分钟前
氢锂钠钾铷铯钫完成签到,获得积分10
3分钟前
ww完成签到,获得积分10
3分钟前
Square完成签到,获得积分10
3分钟前
高分求助中
【提示信息,请勿应助】关于scihub 10000
A new approach to the extrapolation of accelerated life test data 1000
Coking simulation aids on-stream time 450
北师大毕业论文 基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 390
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
Robot-supported joining of reinforcement textiles with one-sided sewing heads 360
Novel Preparation of Chitin Nanocrystals by H2SO4 and H3PO4 Hydrolysis Followed by High-Pressure Water Jet Treatments 300
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 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4015451
求助须知:如何正确求助?哪些是违规求助? 3555379
关于积分的说明 11318024
捐赠科研通 3288651
什么是DOI,文献DOI怎么找? 1812284
邀请新用户注册赠送积分活动 887882
科研通“疑难数据库(出版商)”最低求助积分说明 812012