Comparative analysis of rule elements for transportation of cell therapy products among regulations and standards.

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.

The quality of cell therapy products needs to be ensured during transportation to the hospital, just like during their manufacture. However, cell therapy products are living cells, and ensuring their quality during transportation is challenging. The International Organization for Standardization (ISO) has published ISO 21973 to address this issue, but transport regulations for cell therapy products have not been modified yet. To create draft guidance for the transportation of cell therapy products, it is necessary to analyze the relationship between ISO 21973, good distribution practice, Foundation for the Accreditation of Cellular Therapy Common Standards and ISO 23412. We compared these regulations and standards and identified some elements that are necessary for transporting cell therapy products. These elements are crucial in view of the increasing opportunities to transport allogeneic cells in the future. This study proposed elements to be included in the development of transport regulations for cell therapy products.