Masahiro Kino-oka

Professor
Department of Biotechnology, The University of Osaka
​​

Masa (Masahiro KINO-OKA) is one of leaders in the field of cell manufacturing and contributes to the process development, the design of cell processing facility and automation. His current research interests are “Bioprocess engineering” to establish the cell and tissue manufacturing system including the fields of “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, 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, and finally he earned a current position of Professor in 2009 in Biotechnology, The University of Osaka.
Currently, he started new projects for manufacturing including facility design of cell and tissue processing  for development of guidance for cell and tissue processing (good cell and tissue practice, GCTP). To develop the facility, he has joined to ISO to be international member in ISO TC198 / WG9 for aseptic processing especially, developing ISO 13408-6 isolator system. 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.​

 

Speech title & Synopsis

Development of Robotic Automation System for Cell Manufacturing

Cell therapy and regenerative medicine are rapidly advancing fields offering transformative solutions for diseases that are currently difficult or impossible to treat using conventional medical approaches. Central to their successful clinical and industrial translation is the reliable and scalable manufacturing of therapeutic cells. Unlike traditional pharmaceuticals, cell-based products are living entities that exhibit intrinsic variability and are highly sensitive to environmental conditions and human operations during the manufacturing process. These characteristics introduce significant challenges to achieving consistent quality, safety, and efficacy.
To address these challenges, cell manufacturing must evolve from operator-dependent, craft-based production to a data-driven, standardized, and automated process. Automation not only reduces operator-induced variability but also enables continuous monitoring, precise control of critical process parameters, and traceability across the manufacturing chain. Furthermore, integration of process systems engineering concepts, such as Quality by Design (QbD), and emerging digital technologies, including real-time sensing, AI-based analytics, and digital twins, can facilitate robust process design and predictive control.
This presentation highlights the strategic importance of cell manufacturing in enabling the social implementation of regenerative therapies. It also introduces recent developments in robotic automated platforms in isolator system for  MSCs and iPSCs manufacturing and discusses how “cell manufacturability"—a concept that encompasses biological, environmental, and operational variability—can serve as a foundation for designing next-generation manufacturing systems. By bridging biology and engineering, automation in cell manufacturing will not only ensure product quality and compliance but also expand the accessibility and affordability of advanced cellular therapies worldwide.