End-to-End Scalable Closed iPSC Manufacturing: From Perfusion Expansion to Automated Fill-Finish

This poster presents a closed manufacturing workflow for human induced pluripotent stem cells that integrates carrier-free aggregate expansion, harvest, concentration, formulation, fill-finish, and cryopreservation. A 3 L Vertical-Wheel bioreactor operated with perfusion was compared with a 0.1 L development-scale process. Both scales achieved greater than 54-fold expansion, greater than 97% viability, and comparable aggregate diameters of approximately 530 micrometers. Cells from the 3 L culture were dissociated in the vessel, washed and concentrated by closed counterflow centrifugation, and transferred to an automated fill-finish platform. The 3 L process generated approximately 3.7 billion viable cells, with 100% recovery reported after harvest and 95% post-harvest viability. Post-thaw studies assessed morphology, growth, pluripotency, and genomic stability through five subsequent passages.