バイオ医薬品の連続生産に関するPoints to Considerについて

抄録

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.