Introduction: The development of human pluripotent stem cell (hPSC) culture protocols has led to the establishment of directed differentiation induction methods, resulting in their application in regenerative medicine. Cell therapy products derived from hPSCs have been transplanted into patients, and promising results have been observed in some ongoing clinical trials.
Area covered: This review provides an overview of the challenges associated with the culture of hPSCs for clinical applications and the development of culture technologies designed to address these challenges. We also review future cell culture strategies for large-scale manufacturing to enhance patient access.
Expert opinion: 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. [Figure: see text]Human pluripotent stem cells (hPSCs) show great potential as a valuable resource for regenerative medicine. However, three significant obstacles must be overcome: safety, quality, and costs. Thankfully, recent progress in hPSC culture techniques has effectively tackled these challenges, opening up exciting possibilities for realizing hPSC-based regenerative medicine.
Keywords: Ancillary materials; Cell and gene therapy; Cell culture; Pluripotent stem cells; Regenerative medicine.