设计质量
过程开发
过程(计算)
过程分析技术
计算机科学
质量(理念)
控制(管理)
生化工程
工艺工程
过程控制
组合化学
系统工程
化学
在制品
工程类
物理
人工智能
运营管理
物理化学
粒径
操作系统
量子力学
作者
Antonio Ramı́rez,Daniel M. Hallow,Michaël D. B. Fenster,Sha Lou,Nathan Domagalski,Srinivas Tummala,Shalini Srivastava,L. Hobson
标识
DOI:10.1021/acs.oprd.6b00253
摘要
This manuscript describes the development of a control strategy for impurities in the final intermediate step of the asunaprevir drug substance utilizing the concepts outlined in the International Conference on Harmonisation guidelines (ICH Q8 (R2), Q9, Q10, and Q11). Detailed mechanistic understanding enabled the construction of a kinetic model that was used in conjunction with a process risk assessment and well-defined quality attributes to guide the development of the reaction design space. Implementation of continuous monitoring of the reaction facilitated the expansion of the design space and provided suitable parameter ranges to enable a robust process for commercial manufacturing.
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