Challenges and Solutions for Allogeneic Cell Therapy Manufacturing
This poster reviews key process development considerations required to achieve robust, efficient, and scalable manufacturing of allogeneic cell therapies**.** The authors discuss major scale-up challenges including equipment selection, hydrodynamic control, oxygen transfer, medium exchange, and cell harvest operations. Case studies demonstrate how process optimization and Vertical-Wheel bioreactor technology can reduce seed train requirements, shorten manufacturing timelines, decrease facility footprint, and integrate closed-system operation. The work also presents methodologies for maintaining consistent aggregate morphology through hydrodynamic modulation of energy dissipation rate, improving oxygen mass transfer using external oxygenation strategies, and developing scalable medium exchange and harvest approaches. The poster highlights process-development principles that support commercial-scale manufacturing of stem cell-derived cell products.
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.
How Can We Help?
Tell us what you need and we’ll take it from there.