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Now showing items 11-20 of 24
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." ...
Using value stream mapping to improve documentation processes in the biopharmacutical industry
(Massachusetts Institute of Technology, 2010)
This thesis describes how a 55% reduction in error rate and a 92% decrease in cycle-time were achieved in a batch production records process in a biotech manufacturing facility by utilization of value-stream mapping. The ...
Mergers and acquisitions process improvement in a matrix organization
(Massachusetts Institute of Technology, 2012)
3M has had aggressive growth through acquisitions. Almost all of the acquisitions add new manufacturing sites to the existing manufacturing and distribution networks. 3M is composed of 38 divisions (as of 2011) with ...
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 ...
Strategic development of a manufacturing execution system (MES) for cold chain management using information product mapping
(Massachusetts Institute of Technology, 2011)
The Vaccines & Diagnostics (V&D) division of Novartis recently developed a global automation strategy that highlights the need to implement a manufacturing execution system (MES). Benefits of an MES (electronic production ...
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 ...
Production of AAV vectors for gene therapy : a cost-effectiveness and risk assessment
(Massachusetts Institute of Technology, 2016)
Gene therapy is a promising modality for the potential treatment of rare Mendelian diseases. To date a number of high profile proof-of-concept studies within the industry have demonstrated the significant disease-correcting ...
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 ...
Feature-based investment cost estimation based on modular design of a continuous pharmaceutical manufacturing system
(Massachusetts Institute of Technology, 2011)
Previous studies of continuous manufacturing processes have used equipment-factored cost estimation methods to predict savings in initial plant investment costs. In order to challenge and validate the existing methods of ...