Augmenting drug process development capacity through applications of lean principles and high throughput technology
Name
1051237399-MIT.pdf
Description
Full printable version
Size
21.41 MB
Format
Adobe PDF
Checksum (MD5)
fbc852cbcd5c9f5a8b4131d53f229f7b
Author(s)
Rustia, Maria Dominique Bautista
Advisor(s)
Richard Braatz and Nelson Repenning.
Date Issued
2018
Publisher
Massachusetts Institute of Technology
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.
Description
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).
Subjects
Sloan School of Management.
Mechanical Engineering.
Leaders for Global Operations Program.
MIT Department
Leaders for Global Operations Program at MIT
Massachusetts Institute of Technology. Department of Mechanical Engineering
Sloan School of Management
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