As part of BIO Asia–Taiwan 2025, a special seminar focused on regenerative medicine and cell therapy manufacturing will be held on Friday, July 25, at Room 503, Taipei Nangang Exhibition Center, Hall 1. Organized by PurpleWin Industrial (PWI), this event will highlight cutting-edge innovations in quality-by-design (QbD), process analytical technologies (PAT), and automated platforms for cell manufacturing, featuring two leading Japanese experts.

Prof. Masahiro Kino-oka, from the Graduate School of Engineering at Osaka University, will deliver a presentation titled:
"Development of cell manufacturing automation system: Design of robotic system based on material properties and its application to cell processing in isolation device."
Prof. Kino-oka is a leading authority in the field of regenerative medicine manufacturing, advocating the concept of “Cell Manufacturability.” He specializes in bioprocess design, stem cell bioreactor engineering, and process automation. He currently heads the Cell Manufacturing Technology Center at Osaka University, where he leads joint-industry research labs focused on QbD-based development and standardization. He also actively contributes to ISO technical committees TC198/WG9 (Aseptic Processing) and TC276/WG4 (Bioprocessing), and serves as a committee member of Japan's Ministry of Health, Labour and Welfare for health science policy.

Dr. Ryuji Kato, Associate Professor at the Graduate School of Pharmaceutical Sciences, Nagoya University, will present:
"PAT Realization through QbD: AI-Powered Cell Morphology Analysis for Quality Monitoring."
Dr. Kato has long focused on developing non-invasive, image-based quality control technologies for cell therapy manufacturing. He was the lead architect of Japan’s national standard JIS Q2101 and a contributor to the international standard ISO 24603:2024. His talk will highlight how AI-driven cell morphology analysis can be applied as an in-process PAT solution to ensure process consistency and robust risk management—aligned with recent regulatory trends, including U.S. FDA draft guidance.

This seminar will integrate perspectives from academic research, industrial practice, and global regulatory standards, offering participants a comprehensive look at the future of digitalized and standardized cell manufacturing. Professionals involved in regenerative medicine, advanced therapy manufacturing, quality control, and regulatory strategy are especially encouraged to attend.

🗓 Date: Friday, July 25, 2025 | 13:30–17:00
📍 Venue: Room 503, Taipei Nangang Exhibition Center, Hall 1