基于参数对参数的方法和考虑列外效应的准确和可靠的离子交换色谱模型开发的标准化方法
Yu-Cheng Chen1, Hui-Li Lu2, Rong-Zhu Wang2
1Key Laboratory of Biomass Chemical Engineering of Ministry of Education, Zhejiang Key Laboratory of Smart Biomaterials, College of Chemical and Biological Engineering, Zhejiang University, Hangzhou, China.
对离子交换色谱 (IEC) 建模的标准化方法提高了准确性和可靠性. 这种方法增强了用于工业抗体变异分离的模型概括性,满足监管需求.
科学领域:
- 生物物理化学 生物物理化学
- 化学工程是化学工程的重要组成部分.
- 分析化学 分析化学
背景情况:
- 染色分离建模在准确性,可靠性和监管合规性方面面临挑战.
- 开发一致和验证的模型对于工业生物工艺至关重要.
研究的目的:
- 提出和验证用于离子交换色谱 (IEC) 模型开发的标准化方法.
- 提高工业应用IEC模型的准确性,可靠性和通用性.
主要方法:
- 一个逐步标准化的方法,用于IEC模型校准,包括参数的确定和验证.
- 整合参数对参数 (PbP) 校准方法,并考虑列外效应.
- 使用工业抗体变异分离的验证,采用梯度和逐步实验.
主要成果:
- 标准化方法实现了高精度,大多数校准和验证实验的R2值约为0.9.
- 该方法简化了实验工作量,同时确保了模型外推能力.
- 工业抗体变体的IEC分离证明成功验证.
结论:
- 拟议的标准化方法显著提高了IEC模型的准确性和可靠性.
- 开发的模型适用于更广泛的工业分离系统和模型辅助过程开发.
- 这项工作为符合法规的染色学模型开发提供了坚实的框架.
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