Okudaira Shinichi
Pharmaceuticals and Medical Devices Agency.
Yakugaku Zasshi. 2022;142(7):745-748. doi: 10.1248/yakushi.21-00211-3.
Continuous Manufacturing is a manufacturing method in which raw materials enter the manufacturing process continuously, and products are discharged continuously throughout the duration of the process including multiple unit operations. Continuous Manufacturing includes various options: Those with all stages of processing from charging raw materials to discharging final products that are continuous, and those with only certain parts of the manufacturing process that are continuous. It can be introduced in an appropriate range in consideration of the characteristics of products, manufacturing processes, robustness of processes, etc. Continuous Manufacturing is expected to have the following advantages: A wide range of manufacturing scales are available by adjusting the continuous operation time of the process; it is possible to use the same manufacturing equipment from the development stage to commercial production, eliminating the need to change to large scale manufacturing equipment; and it is possible to reduce the equipment installation area (footprint). While Continuous Manufacturing can be a major manufacturing technique of the pharmaceutical industry in the future, official documents such as guidelines for Continuous Manufacturing are limited. In particular, no official documents such as guidelines specialized in manufacturing of biotechnological drug products have been issued yet. In Japan Agency for Medical Research and Development (AMED) research project, we summarized the key points to consider for investigation of the control strategy for Continuous Manufacturing of biotechnological products as a document. In this paper, we introduce the document.
连续制造是一种制造方法，在该方法中，原材料持续进入制造过程，并且在整个过程（包括多个单元操作）的持续时间内产品持续产出。连续制造包括多种形式：从原材料进料到最终产品出料的所有加工阶段都是连续的，以及制造过程中只有某些部分是连续的。可以根据产品特性、制造工艺、工艺稳健性等因素在适当范围内引入连续制造。连续制造有望具有以下优点：通过调整工艺的连续运行时间可实现广泛的制造规模；从研发阶段到商业化生产可以使用相同的制造设备，无需更换为大规模制造设备；并且可以减少设备安装面积（占地面积）。虽然连续制造可能成为未来制药行业的主要制造技术，但关于连续制造的指南等官方文件有限。特别是，尚未发布专门针对生物技术药品制造的指南等官方文件。在日本医疗研究与开发机构（AMED）的研究项目中，我们将生物技术产品连续制造控制策略研究中需要考虑的要点总结为一份文件。在本文中，我们介绍该文件。
