Enhancing the Speed of Vaccine Development by Utilizing Fully Automated High throughput Cell Potency Assays

High-throughput analytical assays are one of the key enabling strategies which are needed to support vaccine development. The global pandemic response for a Covid-19 vaccine highlighted the need for both rapid assay development and quick sample turnaround to inform process understanding and formulation development. Utilization of an automated platform allowed for increased assay optimization by investigating multiple variables in one experiment instead of evaluating one factor at a time. Additionally, automation allows for expanding assay parameters beyond the limitations of a normal workday. This presentation will highlight how the streamlined development of two cell-based potency assays for a COVID vaccine candidate in under 6 weeks. Utilization of an automated platform with liquid handlers and a dynamic scheduling software allowed for testing multi-variate assays conditions simultaneously. The 96-well µPlaque assay was selected and deployed for a COVID vaccine bioprocess support within accelerated timelines. The final potency assay screened 2,500 samples per month and monitored the key quality attributes to enable process and formulation development.