Development of multiobjective process design method for quality and productivity improvement in pharmaceutical manufacturing

2016 Fiscal Year Final Research Report

• Project/Area Number: 26820343
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Reaction engineering/Process system
• Research Institution: The University of Tokyo
• Principal Investigator: Sugiyama Hirokazu 東京大学, 大学院工学系研究科(工学部), 准教授 (70701340)
• Research Collaborator: Hungerbuehler Konrad ETH Zurich
• Project Period (FY): 2014-04-01 – 2017-03-31
• 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

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.

Free Research Field

プロセスシステム工学