EBMT 2024 | The difficulty in developing predictive potency assays
Valentin Ortiz-Maldonado, MD, discusses the complex issue of developing potency assays with predictive parameters. Current regulations require that advanced therapy medicinal products (ATMPs) undergo a series of checks prior to release, including potency testing. A potency assay must measure potency in a quantitative manner and allow for the prediction of clinical outcomes. Dr Ortiz-Maldonado highlights the difficulty of producing a single assay that can summarize the variability and heterogeneity of the starting material and the disease to accurately predict patient outcomes. This interview took place at the 50th Annual Meeting of the EBMT in Glasgow, Scotland.
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