Augmenting drug process development capacity through applications of lean principles and high throughput technology
Author(s)Rustia, Maria Dominique Bautista
Leaders for Global Operations Program.
Richard Braatz and Nelson Repenning.
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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.
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).
DepartmentSloan School of Management.; Massachusetts Institute of Technology. Department of Mechanical Engineering.; Leaders for Global Operations Program.
Massachusetts Institute of Technology
Sloan School of Management., Mechanical Engineering., Leaders for Global Operations Program.