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
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