Development of innovative management strategy for pharmaceutical continuous manufacturing processes

2023 Fiscal Year Final Research Report

• Project/Area Number: 21H01704
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Review Section: Basic Section 27020:Chemical reaction and process system engineering-related
• Research Institution: Kyoto University
• Principal Investigator: Kano Manabu 京都大学, 情報学研究科, 教授 (30263114)
• Co-Investigator(Kenkyū-buntansha): 金 尚弘 東京農工大学, 工学(系)研究科(研究院), 准教授 (60735504) ; 杉山 弘和 東京大学, 大学院工学系研究科(工学部), 教授 (70701340)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: 医薬品 / 連続生産 / 管理戦略 / プロセス制御 / 異常検出 / 製剤 / デザインスペース

Outline of Final Research Achievements

The goal of this research is to develop innovative control strategies that maximize the quality and productivity of pharmaceutical continuous manufacturing, as well as the methodologies and technologies needed to implement these strategies. We have constructed models for powder feed and mixing processes and developed models using a superstructure to comprehensively represent various equipment configurations. Additionally, we have developed a "greedy design space" approach that maximizes the use of quality-assured operational regions, and a control method that minimizes the risk of deviating from the design space. We have also developed fault detection methods for granulation processes and process selection support tools for solid dosage form manufacturing.

Free Research Field

プロセスシステム工学

Academic Significance and Societal Importance of the Research Achievements

医薬品を低価かつ安定に供給するために，医薬品製造技術の革新が求められている．本研究では，近年採用が進んでいる連続生産を対象として，原料供給，混合，造粒，打錠など主要工程のモデルを構築するとともに，品質制御手法や異常検出手法を含む管理戦略を新たに提案した．これらの成果は，将来の医薬品製造技術の中核技術として，革新的管理戦略構築の基盤となるものである．