Application of lean and continuous improvement methodologies at a biopharmaceutical manufacturing site

Heightened competitive pressures, changes in the regulatory atmosphere, and dropping research and development productivity have been plaguing the pharmaceutical and biotechnology industries. Amgen has felt the effects of these forces and launched a new effort to improve its operations via continuous improvement and Lean, ultimately reducing costs and improving productivity of operations. This thesis examines one example of a process improvement effort at Amgen's Fremont manufacturing facility. This project involved characterizing the cycle times of their buffer solution preparation processes, leading to targeted actions to both minimize variability in the process and to reduce the amount of time and effort to manufacture tanks of buffer solution. Tools and ideas from Lean and Six Sigma were applied and a prioritized action plan was presented to the company. This thesis also provides a broader examination of how such continuous improvement efforts can fit into the biotechnology industry with its idiosyncrasies.

Department dc:contributor.department

Leaders for Manufacturing Program at MIT

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2009

Author dc:creator

• Jay, Wayne G. W

Advisor dc:contributor.advisor

• Roy E. Welsch and Charles Cooney.

• Sloan School of Management.
• Chemical Engineering.
• Leaders for Manufacturing Program.

Statement dc:rights

• M.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.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/50087

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/50087