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Bioprocess equipment & methods for efficient processes: Cell culture, single-use technology, and costing methods for optimized bioprocessing operation

Posted on:2018-01-23Degree:Ph.DType:Dissertation
University:University of Massachusetts LowellCandidate:Perrone, Pietro PFull Text:PDF
GTID:1442390002496527Subject:Biomedical engineering
Abstract/Summary:
The evolution of bioprocessing has been of critical importance to the improvement of health treatments. Overcoming the impact of disabling diseases, improving the quality of life, and the increased life expectancy are all benefits that have their roots in the availability of novel drug products. Many of these novel drug products have resulted from the commercialization of products and manufacturing processes by applying efficient methods that provide high yields and at economically feasible costs.;The development of a new drug extends over many years. It all starts in laboratory results that seem promising (and some that may not seem so promising). The path is tortuous and full of difficult obstacles. Toxicity assessments, establishment of dose and efficacy, patient trials, and finally commercial production is the overall path. There are often detours and adjustments. All these factors contribute to high attrition and correspondingly high costs of development. Applying methods that streamline steps of the process can make the development smoother and efficient. There have been numerous methods that have developed to meet and exceed the requirements of the bioprocessing processes. Many have been borrowed from parallel industries, such as the food and dairy, and fine-tuned for the biopharmaceutical applications. Examples include clarification by filtration or centrifugation, purification by ultrafiltration and chromatography, concentration and virus clearance by ultrafiltration and nanofiltration. This dissertation presents studies in several areas of the drug manufacturing processes that are critical to the success of production. This includes:;1. Grow cells to produce the base drug components -- Bioreactor operation 2. Minimize contamination and maximize flexibility -- Single-Use Technology tubing 3. Optimize production and costs -- System design and costs for unit operations.;Bioreactor operation -- The operation of the bioreactor is at the heart of the biomanufacturing process. Effective cell growth is contingent on operational conditions that protect sterility and provide a comfortable environment for cell growth and harvest processes.;Single Use technology -- Tubing is a main component that replaces inflexible stainless-steel piping with options that provide flexibility and eliminate contamination. It provides a direct scale up path from the laboratory to commercial operations.;System design and costs - Economical manufacturing is important for effectively bringing drugs to market and to produce the drugs at feasible cost for the population to afford. Predicting costs is a key element in optimizing process equipment and streamlining operations.
Keywords/Search Tags:Process, Operation, Methods, Costs, Efficient, Cell, Technology
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