Development of a Commercial Manufacturing Process for Sotorasib, a First-in-Class KRASG12C Inhibitor
A commercial process to manufacture sotorasib (AMG 510), a first-in-class KRASG12C inhibitor, is described. Development efforts focused on rendering a fit-for-purpose early-phase route into a viable long-term commercial process through the reduction of side reactions to improve yield and product qua...
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| Veröffentlicht in: | Organic process research & development 2022-11, Vol.26 (11), p.3115-3125 |
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| creator | Zhang, Liang Griffin, Daniel J. Beaver, Matthew G. Blue, Laura E. Borths, Christopher J. Brown, Derek B. Caille, Seb Chen, Ying Cherney, Alan H. Cochran, Brian M. Colyer, John T. Corbett, Michael T. Correll, Tiffany L. Crockett, Richard D. Dai, Xi-Jie Dornan, Peter K. Farrell, Robert P. Hedley, Simon J. Hsieh, Hsiao-Wu Huang, Liang Huggins, Seth Liu, Min Lovette, Michael A. Quasdorf, Kyle Reifman, Jonathan Robinson, Jo Anna Sangodkar, Rahul P. Sharma, Sonika Kumar, Srividya Sharvan Smith, Austin G. St-Pierre, Gabrielle Tedrow, Jason S. Thiel, Oliver R. Truong, Jonathan V. Walker, Shawn D. Wei, Carolyn S. Wilsily, Ashraf Xie, Yong Yang, Ning Parsons, Andrew T. |
| description | A commercial process to manufacture sotorasib (AMG 510), a first-in-class KRASG12C inhibitor, is described. Development efforts focused on rendering a fit-for-purpose early-phase route into a viable long-term commercial process through the reduction of side reactions to improve yield and product quality, as well as reducing cycle times of crystallization processes by improving particle properties and filtration times. These improvements were key to ensuring clinical supply and commercial launch. The final route consists of five synthetic operations from starting material M-1, including a telescoped two-step sequence, and a final form-setting crystallization. |
| doi_str_mv | 10.1021/acs.oprd.2c00249 |
| format | Article |
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| identifier | ISSN: 1083-6160 |
| ispartof | Organic process research & development, 2022-11, Vol.26 (11), p.3115-3125 |
| issn | 1083-6160 1520-586X |
| language | eng |
| recordid | cdi_acs_journals_10_1021_acs_oprd_2c00249 |
| source | American Chemical Society Journals |
| title | Development of a Commercial Manufacturing Process for Sotorasib, a First-in-Class KRASG12C Inhibitor |
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