| Project/Area Number |
26820343
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Reaction engineering/Process system
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| Research Institution | The University of Tokyo |
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Principal Investigator |
Sugiyama Hirokazu 東京大学, 大学院工学系研究科(工学部), 准教授 (70701340)
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| Research Collaborator |
Hungerbuehler Konrad ETH Zurich
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
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| Keywords | プロセス設計 / 医薬品製造 / 注射剤 / 原薬 / 多目的意思決定 / 品質 / 生産性 / 環境安全 / 固形製剤 / 意思決定 / 経済性 / プロセス改善 / 製品ロス低減 / 製造技術選択 / 環境・健康・安全リスク / 原薬製造 / 製剤製造 / 多目的設計 / 注射剤製造 |
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| Outline of Final Research Achievements |
The aim of this research was to develop multiobjective design method of pharmaceutical manufacturing processes for improving quality and productivity. The following three points are the research outcomes. (1) Process improvement methods in injectable manufacturing processes: the research presented methods for product loss reduction, materials management, and lead time reduction. (2) Decision support method in the process design of injectable and solid drug product manufacturing: the research presented methods for supporting selection of manufacturing technologies and determination of process parameters. (3) Risk reduction method for Environment, Health and Safety (EHS) risks in drug substance manufacturing: the research presented a method for reducing EHS risks of large amount and various types of solvents. In most of the research, case studies were performed in actual processes in order to show the effectiveness of the method.
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