贾思宁,孙艳娜,高栋,王海彬,姚善泾,林东强

• 1:浙江大学生物质化工教育部重点实验室
• 2:浙江大学化学工程与生物工程学院
• 3:杭州博之锐生物制药有限公司

摘要(Abstract)：

针对双柱连续流层析CaptureSMB连续捕获过程，提出了模型辅助过程表征方法。首先，比较了传统实验设计方法(DoE)和模型辅助方法，对6个中高风险参数进行了表征。结果表明，传统DoE方法无法准确表征参数对过程性能的影响，而模型辅助方法可排除无效操作点且考察范围更广。其次，通过模型确定了连接上样流速、连接上样时间和断开上样流速的参数范围，预测了最大过程产率操作点，进一步通过蒙特卡罗模拟和评估操作点的稳健性，得到最优的过程产率操作点。实验结果表明，模型辅助方法准确可靠，节约了时间和材料成本，可为连续捕获过程表征与优化提供指导，促进连续制造的工业应用。

关键词(KeyWords)： 单克隆抗体;连续捕获;层析模型;过程表征;过程优化

Abstract:

Keywords:

基金项目(Foundation): 浙江省重点研发计划(2023C03116);; 国家自然科学基金(22078286);; 国家重点研发计划(2021YFE0113300)

作者(Author): 贾思宁,孙艳娜,高栋,王海彬,姚善泾,林东强

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