A Scalable Xeno-Free Microcarrier-based Suspension Bioreactor System for Biomanufacturing of Human Mesenchymal Stem Cells (hMSCs) for Regenerative Medicine

摘要

We have previously shown that a fed-batch bioreactor process enhances media productivity, and is more cost-effective, and less labor-intensive for large scale expansion of hMSCs in suspension culture. Here we showed that our fed-batch XF bioreactor process achieves hMSC yields of up to 0.5M cells/ml within 5 days at both the small (0.1L) and development (3L) scales while maintaining typical phenotypic and functional properties of hMSCs. We intend to continue to scale this process up to pilot (15L) and production scale (80L) bioreactors, which are critical steps to generating the cell numbers necessary for clinical therapies.