Makoto Sadamitsu

Head, Drug Substance Technical Transfer & Clinical Manufacturing Execution, Biotherapeutics Process Development at Takeda Pharmaceutical Company Limited

Speaker

Since joining Takeda in 2014, he has held leadership roles in biologics GMP manufacturing, technology transfer, facility engineering, and digital transformation. He initially supported clinical trial biopharmaceutical manufacturing and the implementation of single-use technologies, before becoming Manufacturing Manager for biologics GMP operations in 2016. In 2018, he led the planning and establishment of Takeda’s biopharmaceutical manufacturing and research facilities at Shonan Health Innovation Park (iPark), successfully completing the transition and assuming responsibility as Manufacturing Director in 2020. Currently, he oversees drug substance technical transfer, clinical manufacturing execution, and the implementation of next-generation biomanufacturing technologies, including digitalization and advanced manufacturing systems.
Prior to joining Takeda, he worked at Chugai Pharmaceutical Co., Ltd., where he was involved in commercial GMP manufacturing and process development of biopharmaceutical products.
He holds an M.S. in Information Science and Technology Bioinformatics and a B.E. in Applied Sciences from Osaka University.

Externally, Vice President, Chairperson of Symposium Organizing Committee, and Chairperson of JAACT2026, Japan Association of Animal Cell Technology

Vice Chairperson, Policy Issues, Biopharmaceutical Committee, Japan Pharmaceutical Manufacturers Association

A member of Local Scientific Organizing Committee for CMC Strategy Forum Japan

A member of Bioengineering Study Group, Japan Bioindustry Association