2026-09-19T11:00:15Zhttps://dspace.mit.edu/server/oai/requestoai:dspace.mit.edu:1721.1/1179522022-01-27T21:21:28Zcom_1721.1_7582com_1721.1_7581col_1721.1_131023
Richard Braatz and Nelson Repenning.
Rustia, Maria Dominique Bautista
Leaders for Global Operations Program.
Leaders for Global Operations Program at MIT
Massachusetts Institute of Technology. Department of Mechanical Engineering
Sloan School of Management
2018-09-17T15:51:20Z
2018-09-17T15:51:20Z
2018
2018
http://hdl.handle.net/1721.1/117952
1051237399
Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, in conjunction with the Leaders for Global Operations Program at MIT, 2018.
Thesis: S.M., Massachusetts Institute of Technology, Department of Mechanical Engineering, in conjunction with the Leaders for Global Operations Program at MIT, 2018.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 116-121).
The long development lead time and high R&D costs for biologics drugs makes it imperative to eliminate delays and inefficiencies. Limited process development capacity can lead to delays in the availability of life-saving drugs and a large opportunity cost for biopharmaceutical companies. This study investigates the combined viability and impact of two approaches, namely applying lean principles and using high-throughput technology to increase capacity and productivity in pivotal biologics drug process development. Specifically, the project will explore a framework for improved handoffs and work design, and propose management systems to sustain implementation. In parallel, the study tests the sensitivity of the process development cycle to various resource constraints through a discrete event simulation and develops heuristics for the effective use of high-throughput equipment in upstream and downstream processes to increase process development capacity. The two approaches identified a potential increase in throughput of 2.75X (+175%) in preparation for an anticipated 2.3X (+129%) growth in biologics program demand in pivotal process development.
by Maria Dominique Bautista Rustia.
M.B.A.
S.M.
133 pages
eng
Massachusetts Institute of Technology
MIT theses are protected by copyright. They may be viewed, downloaded, or printed from this source but further reproduction or distribution in any format is prohibited without written permission.
http://dspace.mit.edu/handle/1721.1/7582
Sloan School of Management.
Mechanical Engineering.
Leaders for Global Operations Program.
Augmenting drug process development capacity through applications of lean principles and high throughput technology
Thesis
application/pdf
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Publication
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<Abstract>The long development lead time and high R&D costs for biologics drugs makes it imperative to eliminate delays and inefficiencies. Limited process development capacity can lead to delays in the availability of life-saving drugs and a large opportunity cost for biopharmaceutical companies. This study investigates the combined viability and impact of two approaches, namely applying lean principles and using high-throughput technology to increase capacity and productivity in pivotal biologics drug process development. Specifically, the project will explore a framework for improved handoffs and work design, and propose management systems to sustain implementation. In parallel, the study tests the sensitivity of the process development cycle to various resource constraints through a discrete event simulation and develops heuristics for the effective use of high-throughput equipment in upstream and downstream processes to increase process development capacity. The two approaches identified a potential increase in throughput of 2.75X (+175%) in preparation for an anticipated 2.3X (+129%) growth in biologics program demand in pivotal process development.</Abstract>
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