2026-09-19T14:03:28Zhttps://dspace.mit.edu/server/oai/requestoai:dspace.mit.edu:1721.1/733822022-01-28T14:58:32Zcom_1721.1_7582com_1721.1_7581col_1721.1_131023
Roy Welsch and Charles Cooney.
Garvin, Christopher John
Leaders for Global Operations Program.
Leaders for Global Operations Program at MIT
Massachusetts Institute of Technology. Engineering Systems Division
Sloan School of Management
2012-09-27T15:27:29Z
2012-09-27T15:27:29Z
2012
2012
http://hdl.handle.net/1721.1/73382
809794716
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division; in conjunction with the Leaders for Global Operations Program at MIT, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 113-116).
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 product-process 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.
by Christopher J. Garvin.
S.M.
M.B.A.
130 p.
eng
Massachusetts Institute of Technology
M.I.T. theses are protected by
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http://dspace.mit.edu/handle/1721.1/7582
Sloan School of Management.
Engineering Systems Division.
Leaders for Global Operations Program.
Alignment strategies for drug product process development and manufacturing
Thesis
application/pdf
false
Publication
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<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 product-process 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.</Abstract>
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