Integrated "Manufacturing" Systems
Challenges exist throughout the entire scale-up process when culturing large stem cells for therapeutic use. Because the cells themselves are the “product,” the culture system itself must:
• help minimize variability in the cell population;
• effectively control differentiation;
• enable harvesting and formulation without damaging cells; and
• incorporate processes to ensure viability during storage, transport, and administration.
Achieving large-scale production of stem cells while meeting rigorous quality and regulatory standards will depend on further progress in the areas of cell culture and scale-up, characterization, enrichment, purification, and process control to deliver a consistent and reproducible supply of cells in a safe and cost-effective manner.