尺寸排除色谱指纹工作流程,用于开发mAs连续沉过程的流通抛光操作
Mario A Gutierrez-Diaz1, Scott H Altern1, Todd M Przybycien1
1Department of Chemical and Biological Engineering and Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute, Troy, New York, USA.
Biotechnology progress
|January 19, 2026
概括
本研究介绍了单克隆抗体 (mAbs) 两步,流通抛光的工作流程. 该方法有效地去除杂质,实现高mAb回收,并使用活性碳和多模态离子交换树脂显著减少宿主细胞蛋白质.
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
- 下游加工 下游加工
背景情况:
- 单克隆抗体 (mAb) 净化通常依赖于复杂的多步骤过程.
- 现有的方法可能是下游加工 (DSP) 的瓶.
- 流通抛光是一种潜在的强化策略.
研究的目的:
- 为mAbs.开发和验证两步,流通的抛光工艺的工作流程.
- 建立用于同时评估单体产量和杂质去除的指标.
- 为了证明活性炭和多模态离子交换 (MMA) 树脂在流通模式中的有效性.
主要方法:
- 开发了尺寸排除色谱 (SEC) 指纹和一个百分比的SEC清除 (PSC) 度量.
- 使用批量污泥板屏幕选活性炭和MMA树脂.
- 评估的候选材料在单列,更高负载的流通实验.
- 对低分子量 (LMW) 和高分子量 (HMW) 杂质的评估性能.
主要成果:
- 活性炭在酸性,低导电条件下有效地去除了LMW杂质.
- 在随后的步骤中,MMA树脂提供了补充LMW和HMW杂质清除.
- 实现了80%-87%的mAb恢复,将HMW物种减少到1.1%,宿主细胞蛋白减少到<40 ppm.
- 证券交易委员会指纹发现了直角杂质去除,验证了选方法.
结论:
- 基于SEC的杂质分析和PSC指标有效指导流通抛光工艺的开发.
- 使用活性炭和MMA树脂的两步流通过程是mAb净化的一个可行的策略.
- 这种方法加强了DSP,缓解了瓶,并减少了对亲和力捕获的依赖.
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