Recommendations for the validation of flow cytometric testing during drug development: II assays

J Immunol Methods. 2011 Jan 5;363(2):120-34. doi: 10.1016/j.jim.2010.09.036. Epub 2010 Oct 11.


Flow cytometry-based assays serve as valuable tools for various aspects of the drug development process ranging from target discovery and characterization to evaluation of responses in a clinical setting. The integrity of the samples and the appropriate selection and characterization of the reagents used in these assays are in themselves challenging. These concerns taken together with the flow-based technology makes the validation of flow cytometry assays a challenging effort. Therefore, apart from summarizing the role of flow cytometry technology in various stages of drug development, this manuscript focuses on recommendations for the validation of methods applying flow cytometry. Information is also provided on the relevant validation parameters for different types of flow cytometry assays to guide the users of this platform. Together, the recommendations and the information on regulatory guidelines provided in this manuscript represent the consensus of all the authors and can assist the flow cytometry user in implementing the appropriate method validation strategies.

Publication types

  • Review

MeSH terms

  • Drug Discovery / methods
  • Drug Discovery / standards*
  • Flow Cytometry / instrumentation
  • Flow Cytometry / methods
  • Flow Cytometry / standards*
  • Fluorescent Antibody Technique / instrumentation
  • Fluorescent Antibody Technique / methods
  • Fluorescent Antibody Technique / standards*
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / standards
  • Reproducibility of Results
  • Validation Studies as Topic


  • Pharmaceutical Preparations