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 80 mL and 300 mL vessels to evaluate scale-up, growth, productivity, and product quality. The process achieved cell densities of approximately 1.21 million cells/mL and volumetric productivity of approximately 201,000 cells/mL/day. Expanded cells maintained pluripotency and normal karyotype, and process robustness was evaluated using a second hiPSC line. The study demonstrates the feasibility of combining xeno-free media, microcarrier-based adherent culture, and Vertical-Wheel® Technology for scalable hiPSC manufacturing. The workflow is presented as a foundation for future GMP-compatible production processes.
This publication reports a fully suspended process for expansion and six-stage differentiation of human induced pluripotent stem cells into stem cell-derived islets in 0.1 L and 0.5 L Vertical-Wheel® Bioreactors. A fivefold increase in vessel volume produced a twelvefold increase in islet-equivalent yield without compromising islet structure. The 27-day process generated endocrine populations expressing ?-, ?-, and ?-cell markers with glucose-responsive insulin secretion and transcriptomic characteristics approaching adult islets. The study also evaluated donor-derived iPSC lines, cellular…
This protocol provides detailed instructions for expanding mesenchymal stem cells on microcarriers using PBS-Mini bioreactors with Vertical-Wheel technology. The document covers the complete workflow from recovery of cryopreserved MSCs and expansion in adherent culture through inoculation, suspension culture, sampling, medium exchange, and harvest in three-dimensional bioreactor systems the PBS-Mini bioreactor. Recommended process parameters are based on internal optimization studies using multiple MSC lines and media formulations. Guidance is provided for microcarrier preparation, cell…
This protocol provides step-by-step guidance for forming and expanding pluripotent stem cell aggregates in PBS-MINI Vertical-Wheel® bioreactors. The workflow begins with thawing and adherent seed-train culture in T-flasks, followed by transfer to three-dimensional suspension culture in 0.1 L or 0.5 L vessels. Instructions cover inoculation, medium exchange, sampling, morphology assessment, metabolite and pH analysis, cell counting, viability testing, and harvest in the PBS-Mini bioreactor. The document presents recommended starting parameters for seeding density, working volume, agitation…
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