Otsuka Chemical Co., Ltd. and Yokogawa Electric Corporation announced the establishment of SynCrest Inc., a joint venture that will engage in research, development, and manufacturing in the field of middle-molecular pharmaceuticals as a Contract Research, Development and Manufacturing Organization (CRDMO). Set to commence sales operations in May 2023, this new joint venture (investment ratio: Otsuka Chemical 51%, Yokogawa Electric 49%) will provide services to meet various challenges and needs across the pharmaceutical industry's drug development value chain, from research through to commercial production.
Under the shared objective of entering the CRDMO business in the pharmaceutical field, particularly for middle-molecular drugs, Otsuka Chemical and Yokogawa began working in 2020 on the joint development of a flow synthesis method mainly targeting the production of middle-molecular APIs, intermediates, and raw materials. By combining Otsuka Chemical's flow synthesis technology, middle-molecular drug manufacturing technology, and Good Manufacturing Practice (GMP) management know-how with Yokogawa's production process management powered by advanced measurement and control technologies, the companies have developed an industry solution that integrates the continuous flow synthesis method with in-line measurement, making it possible to carry out non-destructive measurements in real-time with a high level of precision.
The newly established joint venture will help researchers and producers of middle-molecular drugs be more productive by providing integrated services ranging from basic drug research through to process development and commercial manufacturing. In addition, the joint venture will respond to challenges and needs related to quality, delivery, and cost in the manufacturing value chain for middle-molecular drugs and other pharmaceuticals that can be chemically synthesized by providing the desired quantity of products at the right time and with optimal quality.
SynCrest will deliver a one-stop service, including library synthesis for drug discovery, process development, manufacturing of experimental medicine for clinical studies, Chemistry, Manufacturing and Control (CMC) support, document preparation for new product releases, and on-demand commercial production. In particular, by greatly reducing the number of manufacturing processes and ratio of impurities for special amidites, the new joint venture can reduce costs and improve purity. A new manufacturing method for special amino acid intermediates has also been developed that enables the synthesis of more than 100 types of non-natural amino acids with high quality and short delivery times. With its in-house development and manufacturing capabilities for special raw materials used in the development of middle- and low-molecular pharmaceuticals, SynCrest aims to be a total solution provider that comprehensively covers the diversified needs of the middle-molecular pharmaceutical field.