Culturing human pluripotent stem cells for regenerative medicine.

Despite the great potential of hPSCs, difficulties such as safety, quality control, and cost management continue to pose obstacles to their product development and clinical translation. A substantial contribution of these issues lies in the cell culture process. Therefore, selecting the appropriate ancillary materials (AMs) and integrating effective culture methods in standard operating procedures (SOPs) from the early stages of clinical development are essential for success. Moreover, incorporating an automated scaling process is imperative to ensure the commercial feasibility of hPSC-based products.