Perfusion Feed and External Oxygenation Utilized to Achieve Linear Scale-Up of iPSC Culture into an 80 L Vertical-Wheel Bioreactor

This poster describes linear scale-up of human induced pluripotent stem cell aggregate expansion across 0.1, 3, 15, and 80 L Vertical-Wheel bioreactors. A baseline small-scale process was used to establish operating conditions and assess robustness across media, operators, cell lines, and agitation rates. Perfusion-based media exchange was introduced to address increasing settlement times and aggregate merging as vessel scale increased. Cell growth, aggregate size, metabolic consumption and production, and pluripotency markers were monitored during scale-up. The 80 L system was operated at a 50 L working volume and generated more than 200 billion PSCs at a concentration above four million cells per milliliter. Cryopreserved cells from the large-scale culture retained a normal karyotype and functional pluripotency. The poster also identifies low-shear oxygen delivery and scalable harvest as critical manufacturing considerations.