FIG. 1.

(A) Illustration of bioprocess for hPSC MCB manufacturing. The cells are thawed from the research cell bank, expanded, and cryopreserved as MCB in current good manufacturing practices facility. This operation requires the cooperation of materials management, facility monitoring, personnel training, and documentation, quality control, and quality assurance. (B) Example of different hPSC banks expanded in different growth conditions, including feeder-culture and feeder-free cultures in a conditioned medium on ECM, a defined medium on ECM, and a defined medium on a synthetic polymer. The cells are thawed from the research cell bank to manufacture MCB and the cells are thawed from MCB to make WCB. Thus, the cells in WCB may have been histologically cultured in different growth conditions. hPSC, human pluripotent stem cell; MCB, master cell bank; WCB, working cell bank; ECM, extracellular matrix.