抗体的界面压力和粘性弹性及其与配方中长期稳定的相关性
Kiet G Pham1, Benjamin R Thompson1, Tingting Wang2
1Department of Chemical & Biomolecular Engineering, Center for Neutron Science, University of Delaware, Delaware 19716, United States.
The journal of physical chemistry. B
|November 2, 2023
概括
单克隆抗体 (mAbs) 的界面粘弹性和表面压力与它们的长期稳定性相关. 界面弹性模块对于预测治疗配方中的mAb稳定性特别敏感.
科学领域:
- 生物物理化学 生物物理化学
- 蛋白质聚合蛋白质的聚合.
- 治疗性蛋白质稳定性 治疗性蛋白质稳定性
背景情况:
- 单克隆抗体 (mAbs) 具有两性质,导致界面上形成粘弹性层.
- 这些界面特性可以促进治疗配方中的蛋白质聚合,影响药物稳定性.
研究的目的:
- 研究空气-水界面粘弹性和mAbs的表面压力及其长期稳定性之间的相关性.
- 为了确定接口风湿学是否可以预测单克隆抗体溶液的稳定性.
主要方法:
- 对五种不同的mAbs测量界面粘弹性质和表面压力.
- 使用3年稳定性研究数据集,可见粒子数量有所变化.
- 使用X射线反射来分析mAbs.的界面结构.
主要成果:
- 表面压力和界面弹性模块都显示出与长期mAb溶液稳定性的强烈相关性.
- 界面弹性模块在区分稳定和不稳定的mAbs.之间表现出高灵敏度.
- X射线反射提供了对界面结构的见解,表明稳定性预测的分子机制.
结论:
- 界面粘弹性特性,特别是弹性模块,作为单克隆抗体稳定性的可靠指标.
- 了解mAb界面行为对于预测和确保治疗性蛋白质配方的长期稳定性至关重要.
- 这项研究为早期检测mAb产品的不稳定性提供了一种潜在的方法.
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