生命周期 DOE-整体发展过程的伴侣
Marco Kunzelmann1, Anja Wittmann1, Beate Presser1
1Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstraße 65, 88397 Biberach an der Riß, Germany.
Bioengineering (Basel, Switzerland)
|November 27, 2024
概括
实验生命周期设计 (LDoE) 集成了生物工艺数据,用于全面的开发. 这种方法增强了模型预测,并使关键过程参数的早期识别成为可能.
科学领域:
- 生物制药工艺开发 生物制药过程开发
- 化学和生物化学工程 化学和生物化学工程
- 数据科学在生物处理中的应用
背景情况:
- 生物工艺开发涉及许多独立的实验研究 (实验设计 - DoE) 具有不同的目标.
- 单独分析DoE研究,阻碍了整合数据,以获得整体的过程概述.
- 在连接单个实验数据集以获得全面的过程理解方面存在挑战.
研究的目的:
- 通过整合数据驱动的过程知识,阐明构建生命周期DoE (LDoE) 的方法.
- 展示LDoE如何在统一设计中通过新的实验促进现有模型的增强.
- 展示LDoE用于过程表征和早期识别潜在关键过程参数 (pCPP) 的应用.
主要方法:
- 制定一个生命周期DoE (LDoE) 战略,整合来自多项实验研究的数据.
- 实施设计增强,将新的实验数据纳入现有模型.
- 将所有生物工艺开发数据整合到一个单一文件和统一模型中.
主要成果:
- 通过LDoE方法,在统一的设计中,可以通过新的实验来增强现有模型.
- 它允许根据主题专家的要求进行灵活的设计调整,增强模型预测.
- 该LDoE整合了所有生物工艺开发数据,使得仅使用开发数据进行过程表征研究.
结论:
- 生命周期DoE (LDoE) 提供了一个统一的框架,用于在整个生物过程开发过程中整合实验数据.
- 这种方法提高了模型的准确性,并允许灵活地适应专家的需求.
- LDoE促进了对潜在关键过程参数的早期识别,使得及时的过程适应和可靠的表征成为可能.
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