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dc.contributor.advisorChristopher L. Magee, Thomas Roemer and Don Rosenfield.en_US
dc.contributor.authorVaudant, Jérômeen_US
dc.contributor.otherLeaders for Manufacturing Program.en_US
dc.date.accessioned2009-01-30T16:30:15Z
dc.date.available2009-01-30T16:30:15Z
dc.date.copyright2008en_US
dc.date.issued2008en_US
dc.identifier.urihttp://hdl.handle.net/1721.1/44303
dc.descriptionThesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division; in conjunction with the Leaders for Manufacturing Program at MIT, 2008.en_US
dc.descriptionIncludes bibliographical references (p. 79-80).en_US
dc.description.abstractWith growing markets and increasing pipelines, biotechnology companies face a supply chain challenge to manufacture and distribute products using economically feasible methods that protect protein integrity. Adequate storage and shipment of drug substance is an important operation and product quality issues are dependent upon success at this stage of the manufacturing process. While cryopreservation technologies are widely in use today, they may become prohibitively expensive in the future due to increasing product volumes and high operational costs.This thesis presents an evaluation of drying technologies as an alternative to cryopreservation for recombinant protein drug substance storage and shipment. After presenting an assessment of current cryopreservation technologies, the potential of drying technologies to protect protein integrity is examined through process optimization and product characterization at laboratory scale. The economic impact of such technologies and the implications of their implementation in the manufacturing environment are discussed. Recommendations on storage technologies for drug substance are proposed based on results of the analysis. Finally, the thesis builds on this particular study to research the specifics of process development in the biopharmaceutical industry and to discuss implications for future process innovation.en_US
dc.description.statementofresponsibilityby Jérôme Vaudant.en_US
dc.format.extent90 p.en_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 Manufacturing Program.en_US
dc.titleEvaluation of drying technologies for storage and shipment of recombinant protein drug substanceen_US
dc.typeThesisen_US
dc.description.degreeS.M.en_US
dc.description.degreeM.B.A.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 Manufacturing Program.en_US
dc.identifier.oclc272397533en_US


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