Evaluation of drying technologies for storage and shipment of recombinant protein drug substance
Name
272397533-MIT.pdf
Description
Full printable version
Size
18.42 MB
Format
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Checksum (MD5)
e3cc482eb3ab38eb7c6619acb879ad89
Author(s)
Vaudant, Jérôme
Advisor(s)
Christopher L. Magee, Thomas Roemer and Don Rosenfield.
Date Issued
2008
Publisher
Massachusetts Institute of Technology
Abstract
With 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.
Description
Thesis (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.
Includes bibliographical references (p. 79-80).
Subjects
Sloan School of Management.
Engineering Systems Division.
Leaders for Manufacturing Program.
MIT Department
Leaders for Manufacturing Program at MIT
Massachusetts Institute of Technology. Engineering Systems Division
Sloan School of Management
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