可操作性
制造工程
过程(计算)
过程开发
钥匙(锁)
工艺工程
计算机科学
工程类
可靠性工程
计算机安全
操作系统
作者
Paul A. Bethel,Lai C. Chan,C. M. Cooper,Gareth J. Ensor,Jerry Evarts,Rustam Garrey,J. Gair Ford,Dan J. Harding,Shaun Hughes,Lucy Jackson,Michael Golden,Kirsty Millard,Andrew Phillips,Andrew J. Robbins,David Short,Alex Telford,David Whittaker
标识
DOI:10.1021/acs.oprd.2c00304
摘要
The development of processes to produce the Bruton tyrosine kinase inhibitor, acalabrutinib 1, has resulted in improvements to the yield, cycle time, and operability, to realize a robust commercial manufacturing process. A highly accelerated clinical program meant that numerous key process challenges had to be resolved in a short timeframe. Issues are discussed, such as the uncontrolled epimerization of a chiral center and the control of the acalabrutinib 1 crystallization step, which was prone to oiling. Specifically, work to understand the complex polymorph landscape of a key intermediate (to facilitate resolution of a filtration issue) is described.
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