{"title":"细胞治疗产品运输法规和标准的规则要素比较分析。","authors":"Yoshihiko Okamura, Shingo Kano","doi":"10.2217/rme-2022-0215","DOIUrl":null,"url":null,"abstract":"<p><p><b>Aim:</b> 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). <b>Methods:</b> 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. <b>Results:</b> The study identified some elements that were present in the PIC/S GDP and other standards but were absent in ISO 21973, and <i>vice versa</i>. These elements are crucial in view of the increasing opportunities to transport allogeneic cells in the future. <b>Conclusion:</b> The study identified the necessary elements that should be included in the development of transport regulations for cell therapy products.</p>","PeriodicalId":21043,"journal":{"name":"Regenerative medicine","volume":"18 8","pages":"611-622"},"PeriodicalIF":2.4000,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative analysis of rule elements for transportation of cell therapy products among regulations and standards.\",\"authors\":\"Yoshihiko Okamura, Shingo Kano\",\"doi\":\"10.2217/rme-2022-0215\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Aim:</b> 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). <b>Methods:</b> 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. <b>Results:</b> The study identified some elements that were present in the PIC/S GDP and other standards but were absent in ISO 21973, and <i>vice versa</i>. These elements are crucial in view of the increasing opportunities to transport allogeneic cells in the future. <b>Conclusion:</b> The study identified the necessary elements that should be included in the development of transport regulations for cell therapy products.</p>\",\"PeriodicalId\":21043,\"journal\":{\"name\":\"Regenerative medicine\",\"volume\":\"18 8\",\"pages\":\"611-622\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2023-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Regenerative medicine\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.2217/rme-2022-0215\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/6/21 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"CELL & TISSUE ENGINEERING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regenerative medicine","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.2217/rme-2022-0215","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/6/21 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"CELL & TISSUE ENGINEERING","Score":null,"Total":0}
引用次数: 0
摘要
目的：本研究旨在通过对温控递送和良好配送规范 (GDP) 的四个相关国际标准进行比较分析，确定细胞治疗产品运输过程中涉及的要素。方法：构建了一个涵盖整个运输过程的分析框架。比较了《药品检验公约》和《药品检验合作计划》（PIC/S）GDP、国际标准化组织（ISO）21973、细胞疗法认证基金会细胞疗法通用标准和 ISO 23412 中对每个要素的描述。结果：研究发现了一些在 PIC/S GDP 和其他标准中存在但在 ISO 21973 中不存在的要素，反之亦然。鉴于未来运输异体细胞的机会越来越多，这些要素至关重要。结论本研究确定了制定细胞治疗产品运输法规时应包含的必要元素。
Comparative analysis of rule elements for transportation of cell therapy products among regulations and standards.
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.
期刊介绍：
Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function*. Since 2006, Regenerative Medicine has been at the forefront of publishing the very best papers and reviews covering the entire regenerative medicine sector. The journal focusses on the entire spectrum of approaches to regenerative medicine, including small molecule drugs, biologics, biomaterials and tissue engineering, and cell and gene therapies – it’s all about regeneration and not a specific platform technology. The journal’s scope encompasses all aspects of the sector ranging from discovery research, through to clinical development, through to commercialization. Regenerative Medicine uniquely supports this important area of biomedical science and healthcare by providing a peer-reviewed journal totally committed to publishing the very best regenerative medicine research, clinical translation and commercialization.
Regenerative Medicine provides a specialist forum to address the important challenges and advances in regenerative medicine, delivering this essential information in concise, clear and attractive article formats – vital to a rapidly growing, multidisciplinary and increasingly time-constrained community.
Despite substantial developments in our knowledge and understanding of regeneration, the field is still in its infancy. However, progress is accelerating. The next few decades will see the discovery and development of transformative therapies for patients, and in some cases, even cures. Regenerative Medicine will continue to provide a critical overview of these advances as they progress, undergo clinical trials, and eventually become mainstream medicine.
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