Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 18 of 18 for “"Biopharmaceutical manufacturing"”.
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Globalization of biopharmaceutical manufacturing
The biomanufacturing industry is changing due to increasing globalization. However, it is changing differently from other high tech industries like software/ semiconductor/ automobiles. In this study we use global biomanufacturing investment data, industry survey data as well as interviews with …
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Variation reduction in biopharmaceutical manufacturing
Thesis (S.M.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 1999.
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Process Analytical Technology in biopharmaceutical manufacturing
… system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality." The biotechnology industry has …
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Model-based Design and Control of Biopharmaceutical Manufacturing Processes
Biopharmaceuticals are products derived from biological organisms for treating or preventing diseases. The global sales of biopharmaceuticals have continually increased for many years and will continue to increase, as the pipeline of product candidates continues to grow. Recent trends in …
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A maturity model for process data analytics in biopharmaceutical manufacturing
The Biopharmaceutical industry continues to add a record number of life-saving biological therapies every year, which builds up pressure to make their manufacturing processes faster, more consistent, and more productive. Increased digitalization is expected to address these needs by means of new …
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Development of a risk management system for consumables used in biopharmaceutical manufacturing
… in place at various stages including consumable manufacturing, receiving inspection, and in-process tests during drug manufacturing which could detect a non-conformance. The total risk level is evaluated as the product of these three dimensions and a threshold is defined for requiring additional …
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Application of lean and continuous improvement methodologies at a biopharmaceutical manufacturing site
… a process improvement effort at Amgen's Fremont manufacturing facility. This project involved characterizing the cycle times of their buffer solution preparation processes, leading to targeted actions to both minimize variability in the process and to reduce the amount of time and effort to …
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Capacity analysis, cycle time optimization, and supply chain strategy in multi-product biopharmaceutical manufacturing operations
… valuable tools for use in pharmaceutical manufacturing facilities. The dynamics of the pharmaceutical industry - market exclusivity, high margins, product integrity and contamination constraints - coupled with increasing cost pressures, demand for specialized products increase, and growing …
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Artificial intelligence infrastructure into material attributes insights
The development of a biopharmaceutical manufacturing process involves an assessment of all possible sources of variation throughout each of the unit operations in the drive toward six sigma manufacturing. The primary goal of this project is to develop a novel way to assess the variation in raw …
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Modeling and economic evaluation of early stage clinical monoclonal antibody manufacturing using single use technology
… 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 manufacturing, but must operate with a high degree of flexibility to respond to emerging …
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Developing scalable and modular technologies for continuous biopharmaceutical production
The existing biopharmaceutical manufacturing paradigm is poorly suited to produce biologic drugs on demand at a point-of-care. Generally, commercial-scale manufacturing using fed-batch cultivation and fixed infrastructure is concentrated in developed nations and results in process cycle times of …
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Separation of Recombinant β-Glucuronidase from Transgenic Tobacco by Aqueous Two-Phase Extraction
Biopharmaceutical manufacturing is a rigorous and expensive process. Due to the medicinal nature of the product, a high purity level is required and several expensive purification steps must be utilized. Cost-effective production and purification is essential for any biopharmaceutical product to be …
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Priority queuing for raw material receiving
The Amgen Manufacturing Ltd. facility in Juncos, Puerto Rico faces a challenge encountered by manufacturers across industries: How can they make the best use of their existing resources? As production volume and product mix increase, how are costs kept from increasing as well? This LGO internship …
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Process developments and critical design attributes in buffer systems for the biopharmaceutical industry
The research presented in this thesis addresses biopharmaceutical buffer management, which has historically received limited attention despite accounting for approximately 20% of the cost of manufacture. Traditional approaches have persisted, resulting in operational bottlenecks, inflexible …
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VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS: DEVELOPMENT AND OPTIMIZATIONOF RELIABLE VIRAL CLEARANCE STRATEGIES
… reproducible, and fully transferable to the biopharmaceutical industry. During the first year, thanks to a structured training period at the Department of Pharmaceutical Sciences (DISFARM), University of Milan, I consolidated essential skills in preparative chromatography and conducted an …
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Data-driven Dynamic Control Scheme for Antibody Producing CHO Cell Cultures in Fed-batch
… process control is a basic requirement for biopharmaceutical manufacturing to achieve high efficiency and enhanced quality control. High non-linearity and uncertainties associated with bioprocesses challenge the ability of traditional controllers to deliver satisfactory performance, thereby …
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Hyperosmolality effects on growth and morphology of CHO cells
… non-ideally mixed large-scale bioreactors during biopharmaceutical manufacturing. It negatively impacts cellular growth and can inhibit productivity, which significantly decreases the robustness and reproducibility of the processes through their up- and downscaling. Surprisingly, hyperosmolality …