Overcoming Bioprocess Bottlenecks Through Advanced Bioreactor Process Development
This publication addresses bioprocess bottlenecks in large-scale human induced pluripotent stem cell expansion using Vertical-Wheel® Bioreactors. Computational fluid dynamics guided scalable inoculation, expansion, harvest, and serial-passaging protocols. Optimized fed-batch culture achieved greater than 30-fold expansion in six days from single-cell inoculation while maintaining homogeneous aggregate morphology. In-vessel aggregate dissociation achieved greater than 95% harvest efficiency and enabled serial passaging and scale-up. Expanded cells maintained normal karyotype, pluripotency-marker expression, and differentiation potential across all three germ layers, supporting scalable hiPSC manufacturing.
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 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…
The PBS Closed-System Sampling Conical supports aseptic, representative sample collection from PBS Vertical-Wheel® Bioreactors while maintaining process integrity and sample quality. The single-use assembly combines a gamma-irradiated vented conical, integrated dip tube, and weldable tubing to reduce contamination risk, handling steps, and operator variability. Compatible with stem cells, immune cells, organoids, and aggregate cultures, it supports routine in-process analyses including cell counts, viability testing, metabolite monitoring, and aggregate characterization.
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