Scalable Culture of Human Induced Pluripotent Cells on Microcarriers Under Xeno-Free Conditions Using Single-Use Vertical-Wheel Bioreactors

This publication reports microcarrier-based expansion of human induced pluripotent stem cells under xeno-free conditions in single-use Vertical-Wheel bioreactors. Cultures were performed in two vessel sizes with working volumes of 80 and 300 mL to evaluate scalability, cell growth, productivity, and product quality. The process achieved cell densities up to approximately 1.21 million cells per milliliter and a volumetric productivity of approximately 201,000 cells per milliliter per day. Expanded cells maintained pluripotency and a normal karyotype, and process consistency was assessed using a second hiPSC line. The study demonstrates the feasibility of combining xeno-free media, microcarriers, and Vertical-Wheel mixing for scalable hiPSC production. The authors position the workflow as a potential foundation for manufacturing hiPSC products under conditions compatible with future GMP implementation.