在法规和标准中对细胞疗法产品运输规则要素的比较分析
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.
Regenerative medicine
|June 21, 2023
概括
这项研究比较了用于运输细胞治疗产品的国际标准. 它确定了制定未来运输法规的基本要素,确保安全有效地提供这些关键的治疗方法.
科学领域:
- 细胞治疗物流 细胞治疗物流
- 生物制药运输标准 生物制药运输标准
- 良好的分配实践 (GDP)
背景情况:
- 细胞疗法产品需要专门的运输来保持可行性和有效性.
- 现有的温度控制配送和国际标准和GDP各不相同.
- 标准的协调对于全球细胞疗法产品的分销至关重要.
研究的目的:
- 通过比较国际标准,确定细胞治疗产品运输中的关键要素.
- 分析制药检查公约和制药检查合作计划 (PIC/S) GDP,ISO 21973,FACT共同标准,以及ISO 23412.
- 为细胞治疗产品的全面运输法规的制定提供信息.
主要方法:
- 开发了一个涵盖整个运输过程的分析框架.
- 进行了四个国际标准的比较分析:PIC/S GDP,ISO 21973,FACT共同标准和ISO 23412.
- 在分析的标准中确定了重叠和独特的元素.
主要成果:
- 确定了一些标准中存在但在其他标准中缺少的关键元素 (例如,ISO 21973).
- 突出了对温度控制交付和GDP的要求的差异.
- 指出这些元素对于未来的异性细胞疗法的运输的重要性.
结论:
- 对比分析揭示了细胞治疗运输当前国际标准中的差距和重叠.
- 确定了对于安全有效的运输至关重要的具体要素.
- 这些发现为为细胞治疗产品制定强大和协调的运输法规提供了基础.
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