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dc.contributor.advisorArnold Barnett and Anthony Sinskey.en_US
dc.contributor.authorSrivali, Nahathaien_US
dc.contributor.otherLeaders for Global Operations Program.en_US
dc.date.accessioned2015-09-29T18:59:40Z
dc.date.available2015-09-29T18:59:40Z
dc.date.copyright2015en_US
dc.date.issued2015en_US
dc.identifier.urihttp://hdl.handle.net/1721.1/99039
dc.descriptionThesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2015. In conjunction with the Leaders for Global Operations Program at MIT.en_US
dc.descriptionThesis: S.M., Massachusetts Institute of Technology, Engineering Systems Division, 2015. In conjunction with the Leaders for Global Operations Program at MIT.en_US
dc.descriptionCataloged from PDF version of thesis.en_US
dc.descriptionIncludes bibliographical references (pages 88-89).en_US
dc.description.abstractAbstract The vision of the Operations Technology Group at Amgen is to enable a robust pipeline through focused and efficient operations research studies. Process design is traditionally developed by performing experiments, but other approaches can be used to improve cost, efficiency, and robustness. The scope of this internship included the use of First Principles, Computational Fluid Dynamics (CFD), and Cross-Product Process Monitoring (CPPM) to improve process design robustness with reduced testing and faster development cycle. The project focused specifically on the drug product development network, which included the development of processes from formulation to filling and finishing, clinical manufacturing, and technology transfer to commercial manufacturing The goal of this internship was to explore opportunities to utilize First Principles, CFD, and CPPM in drug product process design space. First Principles and CFD modeling tools were used to look into the physics of drug product filling process (specifically parameters influencing two key filling issues - drying during line stoppage and dripping between fills). Criteria for analyzing cost and benefits for the use of First Principles were also provided as strategic recommendations on where the new approach should be utilized. Clinical data were leveraged, with multivariate statistical data analysis, to determine inspection reject limit for the purpose of process monitoring and root cause analysis.en_US
dc.description.statementofresponsibilityby Nahathai Srivali.en_US
dc.format.extent89 pagesen_US
dc.language.isoengen_US
dc.publisherMassachusetts Institute of Technologyen_US
dc.rightsM.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.en_US
dc.rights.urihttp://dspace.mit.edu/handle/1721.1/7582en_US
dc.subjectSloan School of Management.en_US
dc.subjectEngineering Systems Division.en_US
dc.subjectLeaders for Global Operations Program.en_US
dc.titleNew approach to drug product process design : leveraging first principles modeling and cross-product process monitoring to improve process design robustnessen_US
dc.title.alternativeLeveraging first principles modeling and cross-product process monitoring to improve process design robustnessen_US
dc.typeThesisen_US
dc.description.degreeM.B.A.en_US
dc.description.degreeS.M.en_US
dc.contributor.departmentSloan School of Management.en_US
dc.contributor.departmentMassachusetts Institute of Technology. Engineering Systems Division.en_US
dc.contributor.departmentLeaders for Global Operations Program.en_US
dc.identifier.oclc921424902en_US


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