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导航前沿:单克隆抗体纯度控制方面的进展

Xiaoyue Song¹, Huairu Tian¹, Rongxian Jing²

¹Suzhou Institute for Drug Control, Suzhou, 215000, China.

Protein expression and purification

|May 9, 2025

概括

本综述详细介绍了用于评估单克隆抗体 (mAb) 纯度的先进分离技术. 染色学和毛细血管电泳的创新增强了生物制药生产中的杂质检测和量化.

科学领域:

生物化学生物化学
分析化学分析化学
生物技术是生物技术.

背景情况:

单克隆抗体 (mAbs) 是关键的治疗药物,需要严格的纯度评估.
传统的mAb纯度分析方法在分辨率和速度方面存在局限性.
确保mAb的完整性对于治疗疗效和安全至关重要.

研究的目的:

审查单克隆抗体 (mAb) 纯度评估分离技术的进展.
突出改进的杂质检测,识别和量化方法.
讨论这些技术在mAb生产和抗体-药物合物 (ADC) 分析中的应用.

主要方法:

探索传统方法:SDS-PAGE,同电聚焦电泳,大小排除色谱.
分析先进的色谱技术:各种高性能液态色谱 (HPLC) 模式.
对mAb结构完整性和杂质分析进行毛细电泳 (CE) 的评估.

主要成果:

先进的技术在杂质分析中提供了更高的分辨率,速度和精度.
染色学方面的创新,包括表面多孔粒子和新型静止相,克服了带宽和吸附等挑战.
这些方法适用于大规模的mAb生产和抗体-药物联合体 (ADC) 分析.

结论:

不断发展的分离技术显著改善了mAb纯度的评估.
先进的染色学和CE方法对于mAb产品的可靠分析至关重要.
在分离科学的持续创新是确保治疗抗体质量的关键.

关键词:

单克隆抗体是一种单克隆抗体.纯度控制纯度控制纯度控制分离技术分离技术.

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