Next generation synthesis instrument for production of peptides

Purpose and goal

The Vinnova project has helped PeptiSystems to establish Proof of Concept for the pilot-scale continuous flow-based peptide synthesis instrument. The goals of the project have been achieved by demonstrating peptide synthesis of medically relevant peptides with high purity and yield that is equal to or better than customers requirements. Purity and yield increased further when scaling up. Customers were involved throughout the project and synthesis methods proposed by them were implemented. A close collaboration has been initiated with one of the largest contract manufacturers.

Expected results and effects

After evaluating the effect of different synthesis parameters the peptide Bivalirudin was synthesized with high purity and yield. When synthesis quantity was scaled up with a factor 10 the results improved further. This proves that the technology works and that the same process can be used to achieve high purity and yield for other peptides. The results that have been generated give credibility and customers are showing strong interest. Patentable innovations have been identified and are under evaluation. The software has improved and facilitates optimization of synthesis methods.

Planned approach and implementation

Syntheses of bivalirudin as a model peptide have been carried out to evaluate the synthesis performance of the prototype instrument. Yields and purities have been determined and compared with customer samples and results that have been achieved with todays industry standard batch reactor technology. Having a continuous dialogue with customers was very important in order to know which reaction parameters need to be tested and which synthesis methods that are relevant for them. Hardware and software were developed in parallel and was influenced heavily by feedback from customers.