Source-Cell Storage Systems for Allogeneic Cell Therapy Products: Comparison of the Regulatory Systems in Target Countries

초록

Background: This study aimed to analyze autologous and allogeneic cell therapies. A gap analysis of source-cell storage regulations and guidelines of allogeneic cell therapies was performed for regulatory authorities in target countries, including the USA, EU, Japan, and Korea. Methods: Cell-storage regulations and guidelines regarding allogeneic cell therapy products framed by regulatory authorities were comparatively analyzed. Results: Of 41 cell therapies, 10 allogeneic cell therapies were selected, and their source cells were categorized based on 3 types of cell storage, namely cell bank (n=6) in the USA, Japan, and Korea; cell stock (n=2) in the EU; and drug substance (n=2) in Korea. In the gap analysis of cell storage regulations and guidelines by the selected regulatory authorities, cell storage systems have regulations and guidelines similar to those stipulated by regulatory authorities, except for the regulation of source-cell changes. Most allogeneic cell therapies used cell banks for cell storage. Thus, to ensure the safety of allogeneic cell therapy, more detailed criteria must be established for source-cell changes in cell storage systems. Conclusion: Regulatory authorities can ensure a safer and more effective supply of therapy products to the public by harmonizing the regulations associated with allogeneic cell therapies.

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