在单克隆抗体治疗中,Mg2+的化诱导了大小和电荷异质性
Himanshu Malani1, Sunil Kumar1, Anurag S Rathore1
1Department of Chemical Engineering, Indian Institute of Technology Delhi, Hauz Khas, New Delhi 110016, India.
International journal of biological macromolecules
|November 17, 2024
概括
(Mg2+) 显著加速单克隆抗体 (mAb) 聚合和化学修饰. 这凸显了需要仔细评估生物制药配方中的金属辅助剂,以确保药物的稳定性.
科学领域:
- 生物制药配方 生物制药配方
- 蛋白质化学 蛋白质化学
- 分析化学是一种分析化学.
背景情况:
- 单克隆抗体 (mAb) 充电变异形状影响稳定性.
- 离子 (Mg2+) 是生物制药中常见的辅助剂和滑剂.
- 了解Mg2+对mAb稳定性的影响至关重要.
研究的目的:
- 为了研究离子 (Mg2+) 对trastuzumab (IgG1抗体) 稳定性的影响.
- 在Mg2+应力下分析尺寸变化和电荷异质性.
- 为了识别由Mg2+和热应力引起的化学变化.
主要方法:
- 尺寸排除色谱 (SEC) 用于聚合分析.
- 阴离子交换色谱 (CEX) 用于电荷变异分析.
- 质谱 (MS) 用于识别化学修饰.
主要成果:
- 与热应力 (~2%) 和对照 (<1%) 相比,Mg2+显著增加聚合 (9%).
- 2+和热应力都使酸性变体水平翻了一番.
- 在压力下发现了17种新的化学修饰 (脱化,异构化,氧化,糖化),其中10种与Mg2+有关.
结论:
- 2+显著增强了mAb聚合和化学修饰.
- 2+的存在需要对生物治疗配方进行彻底的分析.
- 仔细考虑金属辅助剂对于保持mAb稳定性至关重要.
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