Quality Manufacturing of Mesenchymal Stem/Stromal Cells Using Scalable and Controllable Bioreactor Platforms
This publication reviews the scientific and engineering considerations required for manufacturing human mesenchymal stem/stromal cells at clinically and commercially relevant scales. The authors discuss media selection, culture substrates, microcarriers, and scalable bioreactor technologies suitable for adherent cell expansion, including hollow-fiber, fixed-bed, stirred-tank, and Vertical-Wheel® Bioreactors. The chapter examines process optimization, critical quality attributes, critical process parameters, hydrodynamics, harvest efficiency, and scale-down modeling. Emphasis is placed on establishing robust, reproducible, and GMP-compatible manufacturing processes that maintain phenotypic and functional characteristics while supporting scale-up of hMSC production.
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 publication investigates scalable extracellular vesicle production from three-dimensional aggregates of human bone marrow-derived mesenchymal stromal cells cultured in Vertical-Wheel® Bioreactors. Studies evaluated the effects of media and agitation on metabolism, EV biogenesis, yield, and molecular cargo. Dynamic aggregate culture increased EV biogenesis pathway expression and vesicle production relative to static culture. Resulting EVs displayed expected markers and microRNA profiles associated with regenerative and immunomodulatory functions and modulated inflammatory responses in…
This application note describes an hMSC manufacturing workflow using RoosterBio cell products, xeno-free media, and PBS Biotech Vertical-Wheel bioreactors. Studies evaluated microcarrier culture, fed-batch operation, harvest, scale-up, and cell quality. The low-shear, uniformly mixed environment supported robust attachment and cell densities up to 500,000 cells/mL within five days. Fed-batch processing improved media productivity by eliminating routine media exchanges and reducing labor. Comparable growth and metabolite control were maintained across development, pilot, and production…
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