In pharmaceutical development, the establishment of synthetic routes for drug substances and the optimization of reaction conditions are always urgently required. Therefore, it is ideal to complete the product with fewer studies. However, although these are being considered in consideration of the use of batch synthesis methods that are currently widely used in manufacturing, many of them do not produce results according to theory, and detailed tuning of reaction conditions is often required, which therefore requires a lot of time. On the other hand, flow reactions can handle reactions that are difficult to handle with batch methods, and in recent years, many research institutes have been studying them and they have been rapidly developing. However, flow reactions have unique conditions that are not found in batch methods, such as flow rate and tube diameter, in addition to normal chemical reaction conditions, so the number of items to be considered often increases. Taking these into consideration, we were conscious of the number of experiments that can be performed, and used custom planning as a method of investigation that can be done on-site to optimize the flow reaction conditions. We will introduce this method as a useful method from the perspective of obtaining multiple solutions tailored to the situation as a process production.
Joined Kyorin Pharmaceutical Co., Ltd. in 2006. In 2012, he was put in charge of his current position in the Development Synthesis Department. Around this time, he became interested in statistical methods, and studied DoE methods and introduced them to his department. A few years ago, he introduced JMP, and last year, JMP Pro, and is conducting process chemistry research using statistical methods.
