Discussion

High-dimensional flow cytometry is unquestionably the leading technology for cellular analysis because it allows for the simultaneous detection of numerous cellular characteristics on individual cells. Although this technology has become an invaluable tool in Drug Development, Translational Science, and Clinical Laboratories, there is a surprising lack of official validation guidelines specific to flow cytometry. Due to the challenges associated with cellular measurands, the lack of reference materials, and the complexity of the instrumentation, guidelines appropriate to other methodologies cannot fully be applied to flow cytometry. Thus, key stakeholders from both the pharmaceutical and clinical sectors have put forth considerable effort to generate recommendations for the optimization, validation, implementation, and monitoring of flow cytometric methods. In this presentation, the recommendations from the American Association of Pharmaceutical Scientists, International Council for Standardization of Haematology and the International Clinical Cytometry Society, as well as the European Bioanalytical Focus Group will be reviewed. Gaps in the current recommendations and the next steps on the path towards official flow cytometry-specific guidelines will be discussed.

Given that in Translational Science and Drug Development, information and analytical methods are transitioned from non-regulated laboratories to regulated environments, the presentation will also address the minimum requirements for instrument monitoring, assay development, and method validation in a non-regulated environment aimed at maximizing assay translatability to a regulated environment.