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
The drivers for developing the synthetic platform
The challenges of defining a robust control strategy, broadly applicable across a large number of nodes and scales
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
