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Computation and predictive modeling to increase efficiency and performance in cell line and bioprocess development
(Massachusetts Institute of Technology, 2020)
A critical early step in the development of a new biopharmaceutical is the selection of the master cell bank. Per FDA requirements, the same master cell bank must be used for all toxicity and clinical trials, as well as ...
Process Intensification of Spodoptera frugiperda (Sf) Cell Growth via Multi-Parallel Bioreactor System
(Massachusetts Institute of Technology, 2020)
The objective of this project is to improve the yield of the fed-batch manufacturing process for the production of Flublok influenza vaccine, which was approved by the FDA in 2018. In short, Spodoptera frugiperda (SF+) ...
Product management framework for the development of automation solutions for biologics drug substance manufacturing
(Massachusetts Institute of Technology, 2020)
This thesis presents a product management framework for the development of innovative manufacturing automation solutions, and the application of this framework to the development of automation for a continuous biomanufacturing ...
Modeling and economic evaluation of early stage clinical monoclonal antibody manufacturing using single use technology
(Massachusetts Institute of Technology, 2015)
A critical cost driver in the product development process is the manufacturing of clinical trial material supplies. The clinical manufacturing process operates under similar regulatory burdens as commercial biopharmaceutical ...
Application of process analysis and optimization tools in hit-to-lead and lead optimization phases of drug discovery at EPP, NIBR
(Massachusetts Institute of Technology, 2010)
Given that research is based on innovation, it has been believed that its activities can only be optimized with equipment upgrade, increment in personnel scientific knowledge, development of new analytical software and/or ...
Capacity analysis, cycle time optimization, and supply chain strategy in multi-product biopharmaceutical manufacturing operations
(Massachusetts Institute of Technology, 2011)
Application of system optimization theory, supply chain principles, and capacity modeling are increasingly valuable tools for use in pharmaceutical manufacturing facilities. The dynamics of the pharmaceutical industry - ...
Objective assessment of manufacturing technology investments
(Massachusetts Institute of Technology, 2012)
Amgen is a biotechnology company with manufacturing plants throughout the world. New manufacturing technologies are constantly being developed and implemented in order to address cost, quality, regulation, and competitive ...
Using design of experiments to improve a batch chemical process
(Massachusetts Institute of Technology, 2010)
Novartis Vaccines and Diagnostics has made a strong commitment to manufacturing seasonal influenza vaccines through their cell culture technology called Optaflu®. The goal of this project is to improve overall process yield ...
The business case for continuous manufacturing of pharmaceuticals
(Massachusetts Institute of Technology, 2010)
Manufacturing in the pharmaceutical industry is presently characterized as a batch production system, which has existed in its current form for decades. This structure is the result of historical regulatory policy as well ...
Process Analytical Technology in biopharmaceutical manufacturing
(Massachusetts Institute of Technology, 2013)
Process Analytical Technology (PAT) became a well-defined concept within the pharmaceutical industry as a result of a major initiative by the FDA called "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." ...