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

This poster presents development of a scalable xeno-free fed-batch manufacturing process for human bone marrow-derived mesenchymal stem/stromal cells using microcarriers in Vertical-Wheel bioreactors. The process was evaluated across scales ranging from 0.1 L laboratory systems to 50 L production-scale bioreactors. Consistent cell densities exceeding 500,000 cells per milliliter were achieved within approximately five days while maintaining established MSC identity, differentiation potential, cytokine secretion profiles, and immunomodulatory function. Comparable nutrient utilization, waste accumulation, and growth kinetics were observed across multiple reactor scales and donor cell lots. The work demonstrates a scalable manufacturing strategy designed to reduce labor, simplify culture operations, and support translation of hMSC therapies from research through clinical and commercial development.