Featured Session: Development of a Novel Platform to Deliver Large Volume Synthetic Peptides: The Commercialization of Tirzepatide

Learn about the development and commercialization of Eli Lilly's GLP-1 pill.

This special MPC session will feature an in-depth success story from Ely Lilly on their CMC development and commercialization of tirzepatide, a dual GIP/GLP1 receptor agonist approved for treatment of type 2 diabetes. Three speakers will describe the strategy, implementation, and the new manufacturing facility developed.

This case study is expected to have broad appeal to ChE’s beyond the synthetic peptide space given the way the synthesis process and control strategies were developed, the new facility designed to execute the process, and the topical nature of these emerging peptide therapies.

Session Chair: Chris Lowe, Senior Staff Engineer, Takeda Pharmaceuticals & 2025 AIChE Annual Meeting Program Co-Chair

Speakers: Kevin D. Seibert, PhD, Jennifer M. Groh, and Pádraig Murphy, Eli Lilly and Company

Presentation Abstract: The challenge of producing a large volume synthetic peptide necessitated the consideration and development of solutions to a of a number of engineering challenges. Specifically, how a new platform could be developed that provides a flexible and robust process, capable of significant scaleup as needed, all while ensuring the defined control strategy and assurance of consistent quality could be maintained.

In this presentation we will describe three elements of the significant undertaking in the development of the largest volume synthetic therapeutic peptide produced to date.  This includes

1. The drivers for developing the synthetic platform
2. The challenges of defining a robust control strategy, broadly applicable across a large number of nodes and scales
3. And the success of the commercial implementation of the platform and the navigation of the challenges in the startup of a platform with a high degree of novelty and complexity