Flow Cytometry as a Tool for Potency Determination in ATMP Development - WCBP 2025

Purpose

Developing methods to determine potency for Advanced Therapeutic Medicinal Products (ATMPs) is particularly challenging. The assay(s) must strike a balance between science, compliance, and efficiency. Flow cytometry has shown significant potential as a platform for potency assays due to its selectivity, ability to generate multiple data sets from a singular readout, and ability to establish a functional relationship to the therapeutic mechanism of action. There are specific situations in which the application of flow cytometry may offer discrete advantages over traditional and/or matrix assay approaches. Here we share several case studies to demonstrate the application of flow cytometry to the phase appropriate development and/or validation of potency assays for ATMPs including mRNA vaccine (LNP), AAV, plasmid, etc. The detection targets include replacement proteins, surface expressed antigens, and others. Case studies compare flow cytometry with other detection approaches, providing insights into when to use or avoid this technique for potency assays. Finally, the creation of criteria for the qualification, validation and/or transfer of flow methods is discussed to facilitate the implementation of these methods as part of robust potency assurance strategy.

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