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数字双胞胎在高吞吐量染色学过程中开发单克隆抗体

Tiago Castanheira Silva¹, Michel Eppink², Marcel Ottens¹

¹Department of Biotechnology, Delft University of Technology, van der Maasweg 9, Delft, 2629 HZ, the Netherlands.

Journal of chromatography. A

|February 13, 2024

概括

数字双胞胎和高通量过程开发 (HTPD) 加快单克隆抗体 (mAb) 制造. 这种混合方法使用实验和计算方法验证色谱过程,确认收获溶液对树脂性能的影响最小.

科学领域:

生物技术是生物技术.
化学工程是化学工程的重要组成部分.
过程开发过程开发

背景情况:

单克隆抗体 (mAb) 产业日益数字化,数字双胞胎和高通量过程开发 (HTPD) 对于过程验证和创新变得至关重要.
研究澄清的细胞培养超 (收获) 成分对树脂吸附的影响至关重要,但研究不足.

研究的目的:

提出一种混合的HTPD方法,整合了染色体过程开发的实验,计算和决策阶段.
为了研究mAb在收获中对各种蛋白质A树脂的平衡吸附,并将其与纯 mAb实验进行比较.
采用Lumped Kinetic Model来建模列色谱,并分析质量转移系数 (k_ov).

主要方法:

确定了13种蛋白A和16种离子交换树脂的平衡吸附等温体,使用纯的mAb.
研究了在澄清细胞培养中对蛋白A树脂的mAb吸附 (收获).
模拟的柱状染色法用一个块状动力模型来确定总体质量转移系数 (k_ov).

主要成果:

收获溶液成分对mAb对蛋白质A树脂的吸附有微不足道的影响.
观察到k_ov和样本料度之间的线性相关性,与质量转移理论保持一致.
混合HTPD方法有效地整合了计算,实验和决策阶段.

结论:

介绍的混合HTPD方法加速了染色学过程的开发.
开发的白盒数字双胞胎增强了流程理解和验证.
这种方法为优化mAb净化过程提供了一个强大的框架.

关键词:

收获高通量选收获高通量选高通量开发过程的开发过程.一次性运动模型.总体质量转移系数的总体质量转移系数

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