Scaling Up hMSC Production: From Flasks to Vertical-Wheel Bioreactors
Introduction
Mesenchymal stem/stromal cells (MSCs) and MSC-derived extracellular vesicles (EVs) are being investigated in numerous clinical trials, which indicates a growing demand for clinical grade cells. To meet this demand, economical biomanufacturing processes are needed to produce billions to trillions of cells per manufacturing lot (1). Rooster Bio has developed a scalable xenofree (XF) fed-batch hMSC bioreactor process that maintains critical hMSC quality attributes across different vertical-wheel bioreactor scales (0.1L, 3L, 15L, and 50L).
Key Takeaways
- Vertical-Wheel® bioreactors and Rooster MSC cell banks, media, and fed-batch protocols for hMSC and MSC-EV offers scalable method for hMSC expansion and differentiation
- Cell quantity: yields of 500K cells/mL were consistently achieved in just 5 days across 0.1L – 80L scale Vertical-Wheel bioreactors
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