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在中介开发直角选择性mAb下游工艺,以去除与工艺相关的杂质

Dongyoun Jang¹, Mario A Gutierrez-Diaz¹, Scott H Altern¹

¹Department of Chemical and Biological Engineering and Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute, Troy, New York, USA.

Biotechnology progress

|December 16, 2025

概括

这项研究提出了一个in silico工作流程,用于开发快速的非蛋白质A净化过程,以从单克隆抗体 (mAb) 治疗中去除宿主细胞蛋白 (HCP),显著减少净化步骤并提高效率.

科学领域:

生物技术是生物技术.
生物制药制造业生物制药制造业
过程开发过程开发

背景情况:

复合中国大鼠卵巢 (CHO) 表达系统的进步增加了治疗性单克隆抗体 (mAb) 的产生.
更高的生产率导致下游净化过程中宿主细胞蛋白 (HCP) 的负担更大.
有效的医疗人员移除对于mAb的治疗安全性和有效性至关重要.

研究的目的:

开发一个快速的,在中介的工作流程,用于设计三步,非蛋白质A净化过程.
从CHO衍生的mAb疗法中有效地去除宿主细胞蛋白 (HCP).
为了简化下游净化开发.

主要方法:

在选定的树脂,膜吸附剂和新型吸附剂上利用线性梯度屏幕来产生零混因子 (CCF) 和纯 mAb 保留模式.
采用RPLC (逆相液态色谱) "HCP指纹"用于HCP对关键分数的表征.
开发了一个in silico工具来处理保留数据并根据设计约束生成潜在的三步净化序列.

主要成果:

成功设计和完善了几种三步净化工艺,在板尺度上.
通过使用绑定-射捕获,然后通过绑定-射和流通步骤实现了91.4 ppm HCP,累计产品产量为78.7%.
通过使用两个无盐流通步骤,达到96.1ppm的HCP,累计产量为81.4%.

结论:

在 silico 工作流程有助于快速开发有效的非蛋白质A 净化策略mAbs.
开发的流程证明了高效的HCP移除,同时保持了高产品产量.
这种方法为HCP清除提供了传统蛋白质A染色体的可行替代方案.

关键词:

活性炭活性炭的使用方法下游加工是下游加工.宿主细胞蛋白质是宿主细胞中的一种蛋白质.膜色谱学是一种膜色谱学.这是一种单克隆抗体.多式多态色谱学的正交性正交性.

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