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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 ...
Implementation Roadmap and Real Options Analysis for Biopharmaceutical Technology Introduction
(Massachusetts Institute of Technology, 2021-06)
Biologics manufacturing is complex involving several unit operations for drug production. As the industry moves forward, new technologies are introduced to decrease cycle time, reduce costs, and improve quality for these ...
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 ...
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+) ...