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Flow cytometry and pharmacokinetics

    Kevin Lang

    Biomarker Laboratories, PPD, Richmond, VA 23230, USA

    ,
    Katie Matys

    Biomarker Laboratories, PPD, Richmond, VA 23230, USA

    ,
    Patrick Bennett

    Biomarker Laboratories, PPD, Richmond, VA 23230, USA

    &
    Vellalore N Kakkanaiah

    *Author for correspondence:

    E-mail Address: Vellalore.Kakkanaiah@ppd.com

    Biomarker Laboratories, PPD, Richmond, VA 23230, USA

    Published Online:https://doi.org/10.4155/bio-2021-0140

    Multiparametric flow cytometry is a powerful cellular analysis tool used in various stages of drug development. In adoptive cell therapies, the flow cytometry methods are used for the evaluation of advanced cellular products during manufacturing and to monitor cellular kinetics after infusion. In this report, we discussed the bioanalytical method development challenges to monitor cellular kinetics in CAR-T cell therapies. These method development challenges include procuring positive control samples for the development of the method, flow cytometry panel design, LLOQ, prestain sample stability, staining reagents and data analysis.

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