Process Development

A generic drug company approached us with a request to develop a new route for the synthesis of an API. The project involved several milestones, starting with the selection of the route and finishing with a technology transfer by one of our chemists in the client’s facilities. The project was carried out by our development group and all milestones were completed on schedule: selection of one of the three possible routes in the original proposal; development and fine tuning of each step; validation of the process, including preparation of two batches in the scale of hundreds of grams; writing an exhaustive technology transfer report and finally the technology transfer itself. For this final step the project manager spent four days with at the client’s facility, just to be at hand while the process was run from the beginning to end.

The work done included both the identification of the impurities; most of them were intermediates of the route, and its preparation in the scale of 2-3 g each. One of the impurities was especially hard to identify. We worked with an analytical partner, AMSLab, specialised in MS techniques and determination of metabolites, so the structure of the compound was tentatively determined and later checked by total synthesis of the compound. The client received a final package with not only the synthetic method and the technology transfer report, but also all the analytical methods required and the reference standards.