To accelerate cell therapy development and scalability, there is an urgent need to accelerate processing times, increase throughput, reduce cell material requirements for testing, and enhance assay robustness. This presentation will review BlueRock’s approach to achieve this goal: the development of a suite of plate-based assays to characterize our cell therapy products, adaptation to liquid handling platforms, and the development of automated workflows for hands-free operability.

Developing a robust potency strategy for cell therapy products requires a deep, integrated understanding of product characteristics and MoA. By aligning these insights with MoA driven hypotheses, teams can more effectively identify, prioritize, and refine potency assays that are both scientifically meaningful and phase appropriate. The session will highlight practical considerations for early stage programs, including how to balance exploratory analytics with regulatory expectations, how to use characterization data to select surrogate or functional readouts, and how to evolve potency strategies as products advance toward clinical development.