Does automation improve cell-based potency assay development?

BEBPA US Connect 2025 -- Developing precise, accurate and reproducible cell-based potency assays in a GMP environment presents multiple challenges. Potency assay are laborious to set up, requiring on average 2-4 hours of hands-on time (HoT) for a less complex assay with many analysts reporting repetitive motion issues. A single plate potency assay involving a reference and three samples in duplicate involves approximately 200 liquid transfers, and many potency assays require three plates. In a QC environment, traceability of pipetting steps is non-existent, making troubleshooting anomalous results challenging. Method transfer into a QC environment requires several training assays and has varying levels of success dependent on analyst experience. All the above factors contribute to high assay failure rates and a lack of reproducibility, which can lead to drug development delays and increased cost.