Makoto Sadamitsu

Head, Integrated Early Process Development, Biotherapeutics Process Development at Takeda Pharmaceutical Company Limited

Speaker

Joined Takeda Pharmaceutical Company Limited in July 2014, initially engaged in biopharmaceutical manufacturing for clinical trial materials and evaluating single-use equipment implementation at Hikari Plant in Yamaguchi. In 2016, led biopharmaceutical GMP manufacturing as Manufacturing Manager. In 2018, initiated the design and planning for biopharmaceutical manufacturing and research facilities at Shonan iPark. Successfully transitioned functions and built the facility, completing the relocation in 2020, and assumed a leadership role at Shonan iPark as Manufacturing Director. Currently overseeing GMP manufacturing, implementing new biopharmaceutical research and manufacturing equipment, and driving digitalization efforts. Starting April 2025 am also managing responsibilities spanning from early process development to clinical trial manufacturing.

Previously worked at Chugai Pharmaceutical Co., Ltd., focusing on GMP manufacturing of commercial products and process development of biopharmaceuticals.

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

A member of 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