Commercial technology transfer optimization for drug substance process development
Name
1119537637-MIT.pdf
Size
11.41 MB
Format
Adobe PDF
Checksum (MD5)
8848d0200850227da8cf2fb2ef2c52b0
Author(s)
Doucette, Hillary.
Advisor(s)
Richard D. Braatz and Thomas Roemer.
Date Issued
2019
2019
Publisher
Massachusetts Institute of Technology
Abstract
Commercial technology transfer for biopharmaceuticals is the process of transferring process and product knowledge between process development and manufacturing organizations to achieve product realization. This process often occurs before phase 3 of clinical trials, where speed and agility are critical for preventing delays in clinical programs and ensuring commercial site readiness ahead of regulatory approval. As the market is evolving with new modalities and subsequent operational challenges, there is a heightened need to optimize the technology transfer process to sustain growth of products entering an organization's pipeline. This graduate research project seeks to understand the business process workflow of commercial tech transfer and characterize its dynamics using discrete event simulation. Through this quantitative technique of business process modeling, knowledge regarding process bottlenecks and system constraints were revealed, leading to the identification of operational efficiencies which suggest a potential 19.5% reduction in lead times and 31.3% increase in organizational capacity. Furthermore, this work provides a platform for predicting program timelines and resource needs based on preliminary transfer requirements. These predictions can be updated in a Bayesian fashion for real-time project scheduling and capacity planning.
Description
Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2019, In conjunction with the Leaders for Global Operations Program at MIT
Thesis: S.M., Massachusetts Institute of Technology, Department of Electrical Engineering and Computer Science, 2019, In conjunction with the Leaders for Global Operations Program at MIT
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 69-72).
Subjects
Sloan School of Management.
Electrical Engineering and Computer Science.
Leaders for Global Operations Program.
MIT Department
Sloan School of Management
Massachusetts Institute of Technology. Department of Electrical Engineering and Computer Science
Leaders for Global Operations Program
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