Rapid Clinical Translation and Scale-Up of hMSCs and hMSC-EVs
This webinar explores strategies for accelerating development, manufacturing, and commercialization of mesenchymal stem/stromal cell (MSC) and MSC-derived extracellular vesicle products. Topics include scale-up planning, cost-of-goods considerations, quality systems, process development, standardized cell banking, media selection, and robust product characterization. The presentation discusses scalable bioprocess platforms, including Vertical-Wheel® Bioreactors, and provides examples of improved productivity, consistency, and manufacturing efficiency across development and production scales. The webinar also highlights manufacturing considerations for MSC-derived extracellular vesicle therapies and the importance of reproducible processes, quality control, and commercially relevant scale-up strategies.
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…
How Can We Help?
Tell us what you need and we’ll take it from there.