探索和评估模块化概念,用于设计全面的制药制造设施
Maria-Ona Bertran1, Deenesh K Babi1
1API Manufacturing Development Bioprocess Improvement-Optimization, Bagsværd, Denmark.
Biotechnology and bioengineering
|September 4, 2023
概括
这项研究提出了一个in silico方法来评估模块化生物制药工艺设计. 它使用数据,建模和模拟来量化指标,从而实现向灵活的模块化制造转变.
科学领域:
- 生物制药过程设计
- 化学工程是化学工程的重要组成部分.
- 计算建模 计算建模
背景情况:
- 生物制药工艺设计传统上依赖于实验方法.
- 将实验数据与单元和流表模型相结合,可以增强设计探索.
- 模块化工艺设计对于多产品设施来说越来越重要.
研究的目的:
- 为评估模块化生物制药工艺设计提出一个系统的in silico方法.
- 为评估制造业中模块化插件式概念的可行性提供指标.
- 为了促进从传统的专用设计到模块化设计策略的过渡.
主要方法:
- 为模块化设计评估开发一个系统的in silico方法.
- 利用数据,建模和模拟技术.
- 应用不确定性和灵敏度分析用于指标量化.
主要成果:
- 展示用于评估模块化设计的系统方法.
- 通过制造活性药物成分 (API) 进行示例化.
- 量化关键的选择指标,如流程的稳定性和灵活性.
结论:
- 拟议的in silico方法可以对模块化生物制药设计进行可靠的评估.
- 这种方法支持采用模块化的Plug-n-Play概念来实现全面的制造.
- 数据驱动的模拟和分析对于优化生物制药工艺设计至关重要.
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