数字设计的质量在行动中:结晶和隔离的工作流程
Ian Houson1, Humera Siddique1, Magdalene W S Chong2
1CMAC, University of Strathclyde, Glasgow G1 1RD, the United Kingdom of Great Britain and Northern Ireland; Strathclyde Institute of Pharmacy & Biomedical Science, University of Strathclyde, Glasgow G4 0RE, the United Kingdom of Great Britain and Northern Ireland.
International journal of pharmaceutics
|November 3, 2025
概括
本研究介绍了一种通过数字设计 (QbDD) 质量工作流程,用于活性药物成分 (API) 生产. QbDD方法显著减少了实验和材料使用,提高了API制造效率和可持续性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程化学 过程化学
- 数字化转型 数字化转型
背景情况:
- 传统的活性药物成分 (API) 开发面临着制造能力和可持续性方面的挑战.
- 当前的工艺往往需要广泛的物理实验,导致材料浪费和成本增加.
- 整合数字工具可以优化API结晶和隔离,提高效率和产品质量.
研究的目的:
- 以数字设计质量 (QbDD) 工作流为例,用于API结晶和隔离.
- 在实验性减少和材料节省方面评估QbDD的好处.
- 确定数字制药开发领域未来研究的领域.
主要方法:
- 将QbDD工作流应用于具有明显结晶挑战 (聚合,固态形式,缓慢增长) 的三个示例化合物.
- 在QbDD框架内使用数字工具进行流程模拟和优化.
- 与传统的API开发流程进行比较分析.
主要成果:
- 与传统方法相比,QbDD工作流减少了28%的物理实验.
- 通过QbDD方法,API材料的使用量减少了52-65%.
- 观察到效率的提高,即使在需要多次工作流代的复杂情况下.
结论:
- QbDD工作流提供了一条实用的路线,用于在制药开发中实施数字工具,解决技能短缺问题.
- 这种方法导致更可持续和更具成本效益的API生产.
- 该研究促进了制药行业数字设计的标准化.
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