Key considerations & challenges in developing flow cytometry assays for cell & gene therapy products

Abstract

Flow cytometric assays are a vital component of the cell and gene therapy analytics toolbox. In both autologous and allogeneic cell therapy products, key drug product parameters are now evaluated using flow cytometric assays. The complexity of this technique and lack of true reference standards has led to unique challenges during the adoption of flow cytometry assays in quality control as well as during their validation. This article discusses key considerations during assay development and the main challenges in adoption of flow cytometry assays in a quality control laboratory. Further, this article discusses key areas of innovation that can drive the improvement of flow cytometry assays in the future.