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Comparative analysis of rule elements for transportation of cell therapy products among regulations and standards
Yoshihiko Okamura1, Shingo Kano1
1Bio-Innovation Policy Unit, Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, University of Tokyo, Bioscience Bldg B1-17, 5-1-5, Kashiwanoha, Kashiwa City, Chiba 8562, Japan.
Abstract:
Aim: This study aimed to identify the elements involved in the transportation of cell therapy products by conducting a comparative analysis of four related international standards for temperature-controlled delivery and good distribution practice (GDP). Methods: An analytical framework was constructed to cover the entire transportation process. The descriptions of each element in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GDP, International Organization for Standardization (ISO) 21973, Foundation for the Accreditation of Cellular Therapy Common Standards for Cellular Therapies and ISO 23412 were compared. Results: The study identified some elements that were present in the PIC/S GDP and other standards but were absent in ISO 21973, and vice versa. These elements are crucial in view of the increasing opportunities to transport allogeneic cells in the future. Conclusion: The study identified the necessary elements that should be included in the development of transport regulations for cell therapy products.
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