Overcoming Scale-Up Challenges in iPSC Production

This case study evaluates an integrated approach for expansion, dissociation, harvest, concentration, and serial passage of human induced pluripotent stem cells using Vertical-Wheel bioreactors and a single-use tubular-bowl centrifugation platform. Open benchtop centrifugation was compared with closed processing to assess cell recovery and subsequent growth. The closed system achieved 89.9% recovery, compared with 93.3% for the open method, while supporting similar growth after processing. During serial expansion in a 3 L bioreactor, the integrated workflow consistently achieved greater than 90% recovery and greater than 95% post-harvest viability, with spherical aggregates, stable expansion, and maintained OCT4 and SOX2 expression. A process model evaluated processing time and throughput from 60 mL to 80 L, providing a framework for scalable, low-shear downstream processing of iPSC cultures.