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Investigating late stage biopharmaceutical product loss using novel analytical and process technology

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dc.contributor.advisor Noubar Afeyan and Roy Welsch. en_US Hunnicutt, Leigh Anne en_US
dc.contributor.other Leaders for Manufacturing Program. en_US 2008-12-11T18:35:57Z 2008-12-11T18:35:57Z 2008 en_US 2008 en_US
dc.description Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Biological Engineering Division; in conjunction with the Leaders for Manufacturing Program at MIT, 2008. en_US
dc.description MIT Institute Archives copy: pages, 85-86, 87-88, 89-90 bound in reverse order. en_US
dc.description Includes bibliographical references (p. 79-83). en_US
dc.description.abstract The biopharmaceutical industry uses recombinant protein technologies to provide novel therapeutics to patients around the world. These technologies have presented exciting opportunities for breakthrough medical treatments while creating a host of challenges in the discovery, development and manufacture of these products. Protein aggregation is one of the challenges currently limiting the ability to bring new biopharmaceutical products into the market and to manufacture existing commercial products. The mechanisms of aggregation and subsequent particle formation are highly complex, incompletely understood, and difficult to measure quantitatively with currently available analytical tools. Aggregates, and their effect on product appearance, may compromise value to the patient (bioavailability, dose, therapeutic activity and immunogenicity) as well as value to the company (yield loss and performance in a competitive marketplace) and are therefore tightly regulated. This thesis is intended to explore the problem of protein particles through two main avenues: meeting current regulatory criteria and influencing future regulation. Process changes, analytical characterization, and organizational improvements are each addressed to achieve that goal. An experiment was designed and completed to jointly examine (1) changes to manufacturing processes using novel filtration applications intended to reduce or remove protein particles from solution and (2) analytical tools for improved characterization. Organizational dynamics and resource allocation add an extra layer of complexity and are discussed in relation to leveraging knowledge regarding particles. en_US
dc.description.abstract (cont.) Additionally, three objectives are established to influence the direction of future regulation: the need for improved characterization, industry collaboration and a healthy interface with regulatory bodies. en_US
dc.description.statementofresponsibility by Leigh Anne Hunnicutt. en_US
dc.format.extent 90 p. en_US
dc.language.iso eng en_US
dc.publisher Massachusetts Institute of Technology en_US
dc.rights MIT theses are protected by copyright. They may be viewed, downloaded, or printed from this source but further reproduction or distribution in any format is prohibited without written permission. en_US
dc.rights.uri en_US
dc.subject Sloan School of Management. en_US
dc.subject Biological Engineering Division. en_US
dc.subject Leaders for Manufacturing Program. en_US
dc.title Investigating late stage biopharmaceutical product loss using novel analytical and process technology en_US
dc.type Thesis en_US S.M. en_US M.B.A. en_US
dc.contributor.department Sloan School of Management. en_US
dc.contributor.department Massachusetts Institute of Technology. Biological Engineering Division. en_US
dc.contributor.department Leaders for Manufacturing Program. en_US
dc.identifier.oclc 262697848 en_US

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