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Drawing upon our expertise in chemical process R&D and considering valuable insights from our CDMO partners, we meticulously curate our route scouting workflow to rapidly evaluate a range of potential routes by validating bond disconnections and synthetic intermediates and prioritizing the most promising options.
We take great pride in our exceptionally high success rate that defies traditional market standards having addressed and delivered on dozens of route scouting projects, spanning from preclinical development all the way to generics, and with applications on human and animal medicine, key building blocks, agrochemicals and commodity chemicals.
We rank and prioritize the designed routes with the highest potential for scale-up, based on projected cost-of-goods, feasibility on scale and development possibilities. Our route scouting efforts also encompass the exploration of novel synthetic methodologies and the utilization of advanced modern technologies, to enable novel disconnections and meet sustainability criteria, which would be difficult to achieve with more traditional chemistry.
Upon validation of the synthetic sequence, we then identify and prioritize the development needs in order to address the scalability of the reaction protocols, including conversion and selectivity, isolation procedures and purge points, to meet the targeted process efficiency, production cost reduction and enhanced safety profiles, as well as waste minimization and reagent choice, aligning with the sustainability principles of ‘green chemistry’ and in alignment with the ICH guidelines.
A demo batch is usually performed on a 10’s to 100’s g scale to test the robustness of the novel synthesis. A tech transfer package will then be prepared, with SpiroChem supporting the transition to your CDMO of choice.
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