Closed automated large-scale bioreactors for manufacturing mesenchymal stromal cells for clinical use

Over 600 clinical trials using mesenchymal stromal cells (MSCs) or mesenchymal stem cells have been listed on ClinicalTrials.gov. This site is run by the United States National Library of Medicine (NLM) at the National Institutes of Health. Obtaining MSCs for clinical trials is a cumbersome, time consuming, and laborious process when done manually. In addition, the prolonged period of ex vivo expansion includes the risk of the cells becoming microbially infected. This chapter talks about an automated closed system that could be scaled up for manufacturing MSCs for clinical trials. It reviews the design of a semi-automated closed system bioreactor capable of manufacturing mesenchymal stromal cells for clinical use. Terumo BCT sell a machine called the QuantumTM specifically for manufacturing cells, including MSCs, for clinical purposes. The National Institutes of Health analyzed bone marrow stromal cells (BMSCs) from the Quantum system to determine if they retained their differentiation potential