Development of Commercial Manufacturing Processes for Acalabrutinib
ORGANIC PROCESS RESEARCH & DEVELOPMENT(2022)
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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关键词
acalabrutinib, Bruton, tyrosine, kinase, Suzuki, T3P, crystallization
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