As gene-modified cell therapies advance to address new indications, the need for rapid development of robust manufacturing processes becomes increasingly important. Process optimization sets the stage for clinical and commercial manufacturing and plays a foundational role in decreasing time to market and lowering costs of goods (COGs).
This series of case studies presents Design of Experiments (DOE)-driven development of process knowledge and rapid optimization of T-cell expansion in a miniaturized, automated multi-parallel setup as well as the phenotypic analysis of CAR-T cells with donor clustering.