Alignment strategies for drug product process development and manufacturing

The transfer of information between the drug product development and manufacturing organizations is fundamental to drug product commercialization. This information is used to characterize the product-process interaction and ensure manufacturability, and to set operating ranges at fill/finish sites. Amgen has successfully commercialized drug products for years, yet opportunities exist to improve the efficiency of process development and technology transfer, and to better align the equipment, procedures, and data collection of the groups involved in these activities. We identify improvement opportunities and develop a strategic approach, which we term the "Pilot Plant Cooperative," to enable more efficient and effective commercialization. The benefits of this strategy are assessed in three case studies: (1) a capital investment project for new laboratory filling equipment, (2) enhanced data generation in clinical manufacturing, and (3) efficiency improvements in early-stage process development studies. Based on these studies, we make specific recommendations for future work. We make additional procedural and cultural recommendations, including revising capital investment processes and implementing alignment-focused incentives and hiring practices, to ensure widespread alignment is achieved and maintained.

Department dc:contributor.department

Leaders for Global Operations Program at MIT

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2012

Author dc:creator

• Garvin, Christopher John

Advisor dc:contributor.advisor

• Roy Welsch and Charles Cooney.

• Sloan School of Management.
• Engineering Systems Division.
• Leaders for Global Operations 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/1721.1/73382

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/73382