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Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum

van der Strate, B., Longdin, R., Geerlings, M., Bachmayer, N., Cavallin, M., Litwin, V., Patel, M., Passe-Coutrin, W., Schoelch, C., Companjen, A. & Fjording, M. S., Aug-2017, In : Bioanalysis. 9, 16, p. 1253-1264 12 p.

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  • Best practices in performing flow cytometry in a regulated environment

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DOI

  • Barry van der Strate
  • Robin Longdin
  • Marie Geerlings
  • Nora Bachmayer
  • Maria Cavallin
  • Virginia Litwin
  • Minesh Patel
  • Wilfried Passe-Coutrin
  • Corinna Schoelch
  • Arjen Companjen
  • Marianne Scheel Fjording

Flow cytometry is a powerful tool that can be used for the support of (pre) clinical studies. Although various white papers are available that describe the set-up and validation of the instrumentation (the flow cytometer) and validation of flow cytometry methods, to date no guidelines exist that address the requirements for performing flow cytometry in a regulated environment. In this manuscript, the European Bioanalysis Forum presents additional practice guidance on the use of flow cytometry in the support of drug development programs and addresses areas that are not covered in the previous publications. The concepts presented here are based on the consensus of discussions in the European Bioanalysis Forum Topic Team 32, in meetings in Barcelona, Limelette and multiple telephone conferences.

Original languageEnglish
Pages (from-to)1253-1264
Number of pages12
JournalBioanalysis
Volume9
Issue number16
Publication statusPublished - Aug-2017
Externally publishedYes

    Keywords

  • flow cytometry, regulated environment, ASSAYS PRACTICE GUIDELINES, LIGAND-BINDING ASSAYS, T-CELL SUBSETS, DRUG DEVELOPMENT, ACCURATE MEASUREMENT, CYTOKINE RESPONSES, METHOD VALIDATION, CRITICAL REAGENTS, CLINICAL-TRIALS, PART II

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