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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 ...
Genome sequencing technology : improvement of the electrophoretic sequencing process and analysis of the sequencing tool industry
(Massachusetts Institute of Technology, 2005)
A primary bottleneck in DNA-sequencing operations is the capacity of the detection process. Although today's capillary electrophoresis DNA sequencers are faster, more sensitive, and more reliable than their precursors, ...
Critical process parameter determination during production start-up
(Massachusetts Institute of Technology, 2004)
Production start-up data is consistently utilized in a reactive manner during the initial stages of a product's lifecycle. However, if proactive information systems are created before full scale production starts, ramp-up ...
Control and optimization of E. coli picking process for DNA sequencing
(Massachusetts Institute of Technology, 2004)
As part of its responsibility to the National Institutes for Health, the sequencing operation at the Broad Institute strives for cost-effective production. This thesis attempts to reduce variability in the sequencing ...
Information management using Web 2.0 technology
(Massachusetts Institute of Technology, 2009)
Web 2.0, the ultimate platform for tacit based knowledge work has finally arrived. User driven, collaborative platform based tools including wikis, web mash-ups, discussion boards, linkage based search engines, and tagging ...
Fuel cells : manufacturing strategy for emerging technologies
(Massachusetts Institute of Technology, 2001)
Firms attempting to commercialize emerging technologies face unique challenges. Strategy making is one of the major challenges especially when the industry structure is embryonic. In this environment, it is important not ...
Achieving business and operational excellence in the pharmaceutical industry
(Massachusetts Institute of Technology, 2008)
Historically the pharmaceutical industry has been highly profitable. However, the increasing regulatory requirements, bargaining power of buyers, and drug failures together with the threat of biosimilars and decreasing R&D ...
Implementation of the new FDA quality by design guidance in pharmaceutical production
(Massachusetts Institute of Technology, 2008)
Due to the highly regulated environment, it is difficult to implement changes to a pharmaceutical process. Even small change request approvals can require months of effort for pharmaceutical companies and regulatory agencies. ...