Development of Scalable and Robust Manufacturing Processes for iPSC-Derived Therapies Using Vertical-Wheel Bioreactor Platform
This poster, presented at ISSCR Kyoto 2026, demonstrates a scalable strategy for iPSC manufacturing using Vertical-Wheel Bioreactors, addressing expansion, process development, cell banking, and differentiation. Linear scale-up from PBS-0.1 through PBS-80 produced >200 billion iPSCs at a 50 L working volume while maintaining pluripotency and normal karyotype. High-density work cell banks were developed through 3D adaptation and retained differentiation potential toward cardiomyocytes and pancreatic progenitors. MiniPRO further served as a controlled scale-down model, demonstrating growth comparable to PBS-3 and improved cell yield with controlled dissolved oxygen, supporting high-throughput process optimization and future scale-up.
This presentation, presented at ISSCR Kyoto 2026 explores how Vertical-Wheel Bioreactors can reduce development and manufacturing risk for PSC therapies by providing a scalable platform from process development through commercial production. It highlights global clinical trials supported by Vertical-Wheel technology, predictive scale-down with MiniPRO, controlled hydrodynamics, automation, and linear scale-up through PBS-80. Data demonstrate consistent PSC growth across scales, culminating in >200 billion cells from a 50 L batch while maintaining pluripotency, illustrating a practical…
This guide collects and summarizes process parameters from successful experiments performed in Vertical-Wheel® bioreactors, across a variety of cell types including pluripotent stem cells, mesenchymal stem/stromal cells, exosomes and extracellular vesicles, organoids, and immune cells. Find the publication or resource most relevant to your own experiment to help with your process development.
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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