Ryuji Kato

Associate Professor
Nagoya University, Tokai National Higher Education and Research System

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Dr. Ryuji Kato earned his B.Eng. from Tohoku University (1999), M.S. from NAIST (2001), and Ph.D. from Nagoya University (2004). He began his academic career with postdoctoral and assistant professor positions in biotechnology and cell therapy at Nagoya University. Since 2012, he has been an Associate Professor and PI at the Graduate School of Pharmaceutical Sciences, Nagoya University, where he leads the Cell & Molecular Bioengineering Laboratory. He is also affiliated with the Institute of Nano-Life-Systems and the Institute for Innovation for Future Society.
Dr. Kato's research covers a broad range of fields, including bioinformatics, bio-image informatics, regenerative medicine, tissue engineering, and protein/peptide engineering. He has published over 120 scientific papers, holds 36 patents, and has supervised 15 Ph.D. and 60 Master’s students.
His contributions have been widely recognized. He received the Johnson & Johnson Innovation Award and the Terui Award in 2017, the Excellent Paper Award and the Best Technology Award for Next-Generation AI and Robotics in 2018, and the Japan Monozukuri Grand Prize from the Minister of Economy, Trade and Industry in 2022.
In the field of standardization, Dr. Kato has served on ISO/TC 276 since 2014 and led the development of Japan’s first national standard for cell manufacturing (JIS Q 2101), published in 2025. In 2019, he founded Quastella Inc., serving as CEO and now CTO. The company has secured seed funding and over 20 million yen in public research grants.

 

Speech title & Synopsis

Advanced Morphological AI Analysis as a Process Analytical Technology for Quality by Design–Driven Process Development

The industrialization of regenerative medicine has gained momentum in recent years, bringing with it growing expectations for the advancement of novel manufacturing technologies for living cell-based products—an entirely unprecedented domain in modern production. Quality by Design (QbD) offers a strategic framework for quality management in this field, where scientific understanding is still evolving and biological variability remains difficult to control. Unlike traditional Quality by Testing, which relies on partial sampling, QbD emphasizes built-in quality through process understanding and control. However, despite its widespread reference, the QbD concept is often ambiguously defined, and concrete, standardized practices for its implementation in cell manufacturing remain insufficient.
To address this challenge, Japan launched the national project ACE (Advanced Core Ecosystem in Cell Manufacturing) from 2020 to 2024, supported by AMED. This initiative combined advanced engineering research with efforts to establish industrial standards, aiming to bridge the gap between abstract QbD principles and practical applications. A central outcome of the project was the integration of AI-based cell image analysis as a Process Analytical Technology (PAT), enabling the digitalization of in-process measurements and promoting data-driven process optimization.
This presentation will highlight the key outcomes of the ACE project, including the development of JIS Q 2101, Japan’s first national standard for QbD-based cell manufacturing. The talk will also explore how this standard aligns with relevant ISO documents and the emerging role of AI technologies in realizing QbD on the manufacturing floor.