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• W1591160650 abstract "The transfer of information between the drug product development and manufacturing organizations is fundamental to drug product commercialization. This information is used to characterize the productprocess interaction and ensure manufacturability, and to set operating ranges at fill/finish sites. Amgen has successfully commercialized drug products for years, yet opportunities exist to improve the efficiency of process development and technology transfer, and to better align the equipment, procedures, and data collection of the groups involved in these activities. We identify improvement opportunities and develop a strategic approach, which we term the “Pilot Plant Cooperative,” to enable more efficient and effective commercialization. The benefits of this strategy are assessed in three case studies: (1) a capital investment project for new laboratory filling equipment, (2) enhanced data generation in clinical manufacturing, and (3) efficiency improvements in early-stage process development studies. Based on these studies, we make specific recommendations for future work. We make additional procedural and cultural recommendations, including revising capital investment processes and implementing alignment-focused incentives and hiring practices, to ensure widespread alignment is achieved and maintained. Thesis Supervisor: Roy Welsch Title: Eastman Kodak Leaders for Global Operations Professor of Management, Professor of Statistics and Engineering Systems Thesis Supervisor: Charles Cooney Title: Robert T. Haslam Professor, Chemical Engineering" @default.
• W1591160650 created "2016-06-24" @default.
• W1591160650 creator A5079482480 @default.
• W1591160650 date "2012-01-01" @default.
• W1591160650 modified "2023-09-23" @default.
• W1591160650 title "Alignment strategies for drug product process development and manufacturing" @default.
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• W1591160650 hasPublicationYear "2012" @default.
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