Our solutions

The Trivehexin project aims to synthesise a GMP batch for phase II or III studies in preparation for an IMPD submission in the United States. The main objective is to target pancreatic cancer as well as ten other indications currently under study. The major challenge is to ensure access to American and European markets, with a final need for aseptic filling. The synthesis of Trivehexin relies on complex steps, notably the optimisation of purification and the development of advanced analytical methods

Trasis has revolutionised the synthesis of Trivehexin with innovative technical solutions. By optimising the “Click” reaction with an improved copper catalyst, we have reduced the reaction time from 1 hour to just 10 minutes, achieving a 77% conversion to Trivehexin. Our demetallation process using acetic acid and a NOTA-type chelator has lowered the copper residue level to only 10 ppm. Additionally, solid injection purification has increased purity to 99.8%, incorporating the formation of the acetate salt into the purification steps. The overall yield achieved is 47%, with a purity of 99% after dispensing. These improvements allow for a stable, robust and economically optimised manufacturing process.

Trivehexin: the first radiotracer advancing pancreatic cancer treatment