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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 ...
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 ...
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 ...
Optimal handling of Highly Active Pharmaceutical Ingredients during milling and blending operations
(Massachusetts Institute of Technology, 2013)
This thesis investigates best practices for Highly Active Pharmaceutical Ingredient (HAPI) milling and blending. We utilize a qualitative analysis centering on a benchmarking study and quantitative analyses using a ...
Bioreactor Fill Process Control Using Inline Concentration Measurement
(Massachusetts Institute of Technology, 2014)
Some biopharmaceutical companies have responded to evolution of the competitive landscape by placing additional emphasis on reducing their costs of manufacturing as a means of maintaining competitiveness. The prototypical ...
Forecasting resource requirements for drug development long range planning
(Massachusetts Institute of Technology, 2010)
This thesis investigates the use of a task-based Monte Carlo simulation model to forecast headcount and manufacturing capacity requirements for a drug development organization. A pharmaceutical drug development group is ...
Reducing complexity In biomanufacturing operations through single-use assemblies
(Massachusetts Institute of Technology, 2012)
Novartis Vaccines and Diagnostics operates a centralized equipment cleaning and preparation suite at a vaccine production facility in Marburg, Germany. The ~100 pieces of multi-use stainless steel, glass, and plastic ...
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." ...
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 ...