论文标题
基于模型的加速过程开发方法：色谱研究案例研究
A model-based approach towards accelerated process development: A case study on chromatography
论文作者
论文摘要
过程开发通常与冗长的湿lab实验有关，以识别良好的候选设置和操作条件。在本文中，我们介绍了一种基于模型的方法来识别和评估过程设计空间（DSP）的关键特征，从而整合了过程性能和灵活性的分析。提出的方法包括三个主要步骤：（1）模型开发和问题制定，（2）DSP识别和（3）DSP分析。我们演示了如何将这种方法用于识别可接受的操作空间，以评估不同的操作点和过程灵活性的量化。上述步骤在蛋白质上是对生物制药制造中使用的基于抗体的疗法的色谱纯化。
Process development is typically associated with lengthy wet-lab experiments for the identification of good candidate setups and operating conditions. In this paper, we present the key features of a model-based approach for the identification and assessment of process design space (DSp), integrating the analysis of process performance and flexibility. The presented approach comprises three main steps: (1) model development & problem formulation, (2) DSp identification, and (3) DSp analysis. We demonstrate how such an approach can be used for the identification of acceptable operating spaces that enable the assessment of different operating points and quantification of process flexibility. The above steps are demonstrated on Protein A chromatographic purification of antibody-based therapeutics used in biopharmaceutical manufacturing.
