Development of Scalable, Versatile, and Cost-Effective Processes for iPSC-Derived Cell Therapy Manufacturing via Linear Scale-Up and High-Density Cell Banking Approaches

This poster presents a three-dimensional bioprocess for linear scale-up of human induced pluripotent stem cell expansion from 0.1 L through an 80 L Vertical-Wheel bioreactor. Growth kinetics, aggregate sphericity, pluripotency-marker expression, karyotype, and functional pluripotency were assessed across scales. The workflow also generated high-density working cell banks through serial aggregate culture and scalable harvest, wash, concentration, and cryopreservation operations. Post-thaw cell banks maintained viability, growth performance, genomic stability, and differentiation competence. The banks were used in shortened workflows for producing endocrine or islet-like cells and cardiomyocytes. The poster addresses variability associated with lengthy planar seed trains by proposing direct thaw into three-dimensional expansion before differentiation. Results support a scalable manufacturing framework that combines aggregate expansion, high-density banking, and lineage-specific differentiation.