Immunophenotyping of Cellular Therapy Products Against Oncogenic and Viral Targets.

Flow cytometric analysis can provide valuable information on the viability, phenotype, and therapeutic potential of cell therapy products using a minimal amount of cell numbers. In this chapter, we describe methods for the analysis of clinical products that incorporate extra considerations within the protocols to help maintain consistency and confidence of staining. This can include methods for evaluating the transduction efficiency for T cells expressing chimeric antigen receptors (CAR-T), characterizing the frequency of diverse lymphocyte populations within polyclonal cell cultures and postinfusion research samples, and measuring the activity or exhaustion in response to antigen-specific stimulation. This chapter also includes recommendations for storage and management of staining materials, frequency of compensation analysis, and reference standards.