Masahiro Kino-oka Department of Biotechnology, Graduate School of Engineering, Osaka University & Research Base for Cell Manufacutrability, Graduate School of Engineering, Osaka University

Masa (Masahiro KINO-OKA) is one of the leaders in the field of manufacturing for cell and tissue products; individuals who seem able to contribute to the standardization of the cell processing facility and bioreactor. His current research interests are “Bioprocess engineering” to establish the cell and tissue manufacturing system including the fields of “Bioreaction Engineering”, “Bioprocess design”, and “Stem Cell Engineering”, advocating “cell manufacturability” which leads to stable and cost-saving system for manufacturing of stem cells.

Toward, the current professional status, Masa earned his B.S. in Department of Chemical Engineering at The University of Osaka in 1989, and M.S. in 1991. He became the research assistant, Department of Chemical Engineering, The University of Osaka (1991-2000), having the project of bioreactor and process design for plant tissue culture. After getting the Ph.D. in 1996, he spent one year as a visiting staff in the Department of Chemical Engineering, National Institute of Switzerland (ETH) in Zurich and started the new project for bioreactor design for human cells toward clinical application.

After returning Japan (1997), he promoted twice in his five-year tenure (Assistant Professor, Department of Chemical Engineering, The University of Osaka (2000), Associate Professor, Department of Chemical Engineering, The University of Osaka (2003), and finally he earned a current position of Professor in 2009 in Biotechnology, The University of Osaka.

Prior to Department of Biotechnology, Masa had many experiences for bioreactor and process designs for plant and human cell cultures. He started new projects for manufacturing including facility design of cell and tissue processing (Development of cell manufacturing and processing system for industrialization of regenerative medicine (2014.4-2019.3), Development of scale-up cell manufacturing system to meet the industrialization for regenerative medicine(2019.10-2021.3), and Establishment of QbD-based control strategy and advanced core ecosystem in cell manufacturing (2020.11-2025.3) by Japan Agency for Medical Research and Development (AMED)) for development of guidance for cell and tissue processing (good cell and tissue practice, GCTP).

 To develop the facility, he has joined to ISO as international member in ISO TC198 / WG9 for aseptic processing as well as ISO TC276 / WG4 for bioprocessing. In addition, he becomes board of directors of the Japanese Society for Regenerative Medicine (JSRM) and Health Science Council member in Minister of Health Labor and Welfare (MHLW), collaborating with regulatory site of Japanese FDA (PMDA) to establish guideline for aseptic cell processing.

Masa also has established “Research Base for Cell Manufacturability” in The University of Osaka since 2021 to develop practical system for cell manufacturing, guidance for regulation and standard as well as human resources for process design. Several companies gather to open their laboratories inside The University of Osaka, making up the core of the consortium management.