Transfer and Validation of Flow Cytometry Assay Across Platforms and Labs

A cell-based flow cytometry potency assay was developed and will be validated, transferred and implemented on two platforms- CytoFlex and BD FACSlyric. This allowed for the evaluation of their respective capabilities, including sensitivity, accuracy, throughput, equipment, and software ease of use. This comparison allowed us to decide which platform best suits the requirements of a cell-based flow cytometry potency assay for cross site validation. The assay validation design is outlined to access specificity, robustness, accuracy, precision, linearity, range and precision. Key challenges will be discussed.