Scaling Up hMSC Production: From Flasks to Vertical-Wheel Bioreactors

This application note describes a scalable manufacturing workflow for human bone marrow-derived mesenchymal stem/stromal cells using RoosterBio cell products, optimized media systems, and PBS Biotech Vertical-Wheel bioreactors. The document summarizes process development studies covering inoculation conditions, microcarrier culture, fed-batch operation, harvest methods, scale-up strategies, and quality assessment. Expansion performance was evaluated across multiple reactor scales while monitoring cell growth, phenotype, differentiation potential, immunomodulatory activity, and cytokine secretion. The publication also discusses media productivity, donor reproducibility, and operational efficiencies obtained through fed-batch processing. The resulting workflow provides a practical framework for scaling MSC production and supporting future manufacturing of both MSC-based therapies and MSC-derived extracellular vesicle products.