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 20 of 20 for “"Drug Manufacturing"”.
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Development of a micro-feeder for cohesive pharmaceutical powders
… industry has been striving to improve drug manufacturing processes to enable the accurate production of small batches for precision medicine and small-scale clinical trial medicine manufacturing. This aims to reduce manufacturing costs, improve drug manufacturing effectiveness, and …
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Design of a rapid, continuous, small-scale device for creating dry powders from concentrated suspensions containing active pharmaceutical ingredients
… batch processes. The minimum time-to-patient for drug manufacturing is approximately 100 days. Using a continuous manufacturing process, the time-to-patient could be reduced to less than ten days. The scope of this paper encompasses the design of a machine for the desiccation of a mixture of …
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Establishment of a novel Pichia Pastoris host production platform
… Development group at Amgen is responsible for manufacturing and optimizing the cell lines utilized in production of Amgen's biologic drug portfolio. Traditionally, these cell lines are produced from mammalian host organisms, primarily Chinese Hamster Ovary (CHO) cells, due to their unique …
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Design of a cultivation medium for protein production in Pichia pastoris based on genome-wide biological understanding
… of non-mammalian host organisms for biologic drug manufacturing could lead to step-changes in cost of manufacturing and volumetric productivity, increasing access to these life-saving drugs for large patient populations. One promising alternative host is Pichia pastoris, a methylotrophic yeast …
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Particle assisted protein crystal nucleation as a protein purification platform for pharmaceutical manufacturing
… separation and purification strategy in protein drug manufacturing. This work investigates the use of functionalized nanoparticles in solution to act as in situ templates for initiating crystal nucleation. We used lysozyme, a protein with well-characterized crystallization conditions, to evaluate …
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Interactions at interfaces across scales : from adsorption to adhesion
… of crystals for applications in protein-based drug manufacturing.
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Tactical planning optimization for campaign scheduling of active pharmaceutical ingredient production based on monoclonal antibodies
… to reduce the financial burden associated with drug manufacturing. Consequentially, Novartis Pharma Technical Operations' is currently engaging in efforts to obtain Class "A" Manufacturing Resource Planning (MRP II). This project was chosen to analyze and address the current Integrated Business …
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Facilitating Adoption of Continuous Manufacturing Platforms in the Pharmaceutical Industry
Continuous manufacturing (CM) of pharmaceutical products has gained a great deal of interest over the past decade. CM promises multiple benefits to all pharmaceutical industry stakeholders; however, pharmaceutical manufacturers generally have been slow to invest in the technology and even slower to …
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Spray drying as part of the continuous manufacturing value proposition at Novartis
… is considering a complete overhaul of their manufacturing processes. To date, all drugs have been made by using a batch process. In an attempt to lower costs, Novartis is evaluating moving some drug production to a continuous process. Novartis has instituted lean in their production plants …
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Implementation Roadmap and Real Options Analysis for Biopharmaceutical Technology Introduction
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 processes. Amgen aims to innovate, improve, and transform through a culture of …
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Design and development of components of a modular bioreactor
Biologic drug manufacturing is traditionally conducted in large-scale, industrial bioreactors. The emergence of interest in disposable, bench-top bioreactors as a viable alternative is due to potential advantages such as lower contamination risk, time and cost savings, and ease of handling. The …
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Optimization of warehouse operations and transport risk mitigation for disposable bioreactor bags to support launch of Amgen Singapore Manufacturing
… As part of this goal, Amgen is launching a new manufacturing site in Singapore (ASM). Reliability of supply and quality control will be critical factors for successful ASM launch; therefore, this project will focus on two key objectives: optimization of raw material flow for the ASM warehouse, …
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Pilot study : Investigating the chemical composition of illegal drugs and the associated prevalence of the different drug types in the Bellville and Athlone police districts in the Western Cape, South Africa
… can be attributed to the fact that possession of drugs constitutes a criminal offence. Not much research is done, and with the exception of self-reported, rehabilitation institution data, from the South African Community Epidemiology Network on Drug Use (SACENDU) and the South African Police drug …
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Development of a risk management system for consumables used in biopharmaceutical manufacturing
Injectable drugs, like those manufactured by the BioPharmOps group of Novartis Pharmaceuticals AG, must conform to strict guidelines for purity and potency. Recent non-conformances of critical supplied consumables have revealed potential business and patient safety risks for biotechnology …
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Porter's strategy and the influence of guanxi and government policies in small and medium-sized pharmaceutical companies in China
… medium-sized companies and having prescription drug manufacturing capability. A critical realist approach was adopted with a semi-structured interview technique to collect primary data from nine interviewees, four of whom provided a second follow up interview to explore guanxi giving a total of …
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Turbulent mixing and chemical reaction in baffled stirred tank reactors : a comparison between experiments and a novel micromixing-based computational fluid dynamics model
… most important steps in process development for drug manufacturing or fine chemical production. In many situations the kinetics of product formation can be quite complex and involve a number of intermediate steps as well as parallel and serial reactions. This renders the systems sensitive to the …
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Analytics-Enabled Quality and Safety Management Methods for High-Stakes Manufacturing Applications
… is a critical aspect of the management of manufacturing processes, particularly in industries where product reliability and safety are paramount. With increased digitization and automation, there is growing potential for analytical tools combined with ubiquitous data to aid the transition …
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Investigation of a process analytical technology (PAT) for rapid cleaning verification in the pharmaceutical industry to reduce product changeover time
… FDA’s recent citation where it said, most of the drug manufacturing-related problems leading to product recalls and manufacturing disruption are caused by cross-contamination. Another immense drawback of the current technique is that it may take up to 3 weeks to complete the verification study, …
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Stereoselective and Economical Methods for Chemical Synthesis of Essential Medicines
… the exploration of diverse chemical space during drug discovery, and by encouraging the development of economical and sustainable solutions in active pharmaceutical ingredient (API) manufacturing. For a given API, a single stereoisomer often displays preferable chemical and pharmacological …
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Fluid Agitation Studies for Drug Product Containers Using Computational Fluid Dynamics
… the movement of unwanted particles in Amgen's drug product containers. For quality inspection, the AVI system must detect these undesired particles using a high speed spin-stop agitation process. To better understand the fluid movements to swirl the particles away from the walls, Computational …