MiniPRO Vertical-Wheel Bioreactor System as an Efficient Scale-Down Model for iPSC Process Development, Enabling Process Control, Perfusion Culture, and Closed Operation

This poster evaluates the MiniPRO, a scaled-down, computer-controlled Vertical-Wheel® bioreactor platform, for expansion of human induced pluripotent stem cells (iPSCs). Oxygen-controlled MiniPRO cultures were compared with non-controlled systems across conventional inoculation and direct-thaw workflows. Results showed consistent aggregate size distributions, preservation of pluripotency markers SOX2 and OCT4, and enhanced process control through dissolved oxygen regulation. Scale-up studies demonstrated comparable growth kinetics, metabolite profiles, and aggregate characteristics between MiniPRO and PBS-3L systems, supporting MiniPRO as a representative scale-down model for efficient process development and reduced scale-up risk in PSC manufacturing.

This white paper examines the cost and operational advantages of scaling cell therapy manufacturing with Vertical-Wheel® bioreactors compared with planar culture and stirred-tank systems. It evaluates expansion efficiency, labor, facility footprint, process consistency, contamination risk, and cell quality. Published studies in hiPSCs and MSCs are used to assess yield, handling requirements, reproducibility, viability, phenotype, potency, and scale-up performance. A side-by-side cost comparison, including a 3 L PBS Biotech system, illustrates how Vertical-Wheel bioreactors can support a more streamlined and scalable manufacturing approach while recognizing that actual costs depend on the specific process.

This application note demonstrates expansion of CAR-NK cells in PBS Vertical-Wheel® Bioreactors integrated with the Repligen XCell® ATF 2 perfusion system. Human NK cells were activated, CAR-transduced, and expanded using batch, fed-batch, and perfusion strategies, with performance evaluated across growth, nutrient utilization, metabolites, cell health, CAR expression, and potency. Fed-batch improved expansion over batch culture, while perfusion further increased yield. A responsive perfusion strategy based on cell density and glucose consumption delivered the highest expansion with efficient media utilization while maintaining cell health, supporting PBS Vertical-Wheel bioreactors as a scalable platform for CAR-NK manufacturing.