Year: 2006-07

Company: Amylin Pharmaceuticals

Liaison(s): Christine Mendoza

The transition between development and manufacturing for clinical and commercial purposes poses many unique challenges. Manufacturing and facility constraints and other scale-up issues need to be overcome before production can reach a scale adequate to supply clinical trials and/or commercial needs. The objective of this Team Masters Project has been to work with Amylin Pharmaceuticals to perform a process investigation and development to define a large-scale and business viable manufacturing process for a new therapeutic candidate. The team focused on the replication of portions of the downstream purification process to examine the feasibility of an alternate unit operation. One challenge was the implementation of a laboratory scaleddown model of the manufacturing process. However, the group succeeded in conducting extensive laboratory experiments to support a recommendation for implementing post-IND process changes. Experimental analysis was supported by SuperPro simulation software, which was utilized to forecast the effects of changes and provide reports to conduct operational and cost analysis.