Process innovation is crucial to enable the scalable, efficient, and robust commercial manufacture of sotorasib. This presentation demonstrates the innovative accomplishments during the development of the sotorasib commercial manufacture process through a few case studies. The first example showcases the process development of classical resolution approach to access enantioenriched atropisomer in a sustainable and scalable fashion, which is essential to enable rapid commercial advancement of sotorasib. Furthermore, CM enabled racemization of the undesired isomer allows recycling the waste to further improve the process greenness. The second case study highlights the kinetic and mechanistic investigation of a Suzuki Cross-Coupling reaction, one of the key GMP steps of sotorasib manufacture. The enhanced process knowledge obtained from this effort further ensures the process robustness. Finally, by leveraging advanced PAT tools, the process efficiency and cycle time are significantly improved by addressing a previously problematic isolation process through systematic optimization of crystallization.

Process innovation to enable the scalable manufacture of sotorasib

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