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研究抗体聚合和聚合抑制的方便策略:特征和模拟

Yibo Guo¹, Xi Chen¹, Guchen Fang¹

¹State Key Laboratory of Bioreactor Engineering, Department of Bioengineering, East China University of Science and Technology, 130 Meilong Road, Shanghai 200237, China.

|April 26, 2025

概括

这项研究引入了一种快速模拟方法,以了解抗体聚合和辅助剂效应. 这些发现与实验数据保持一致,为配方开发提供了具有成本效益的方法.

科学领域:

生物制药配方生物制药配方
蛋白质聚合机制蛋白质聚合机制
计算化学是一种计算化学.

背景情况:

基于抗体的药物在加工和配方过程中面临蛋白质聚合的挑战.
传统的研究辅助剂对聚合效应的方法耗时且昂贵,需要大量的抗体.

研究的目的:

开发一种快速,小规模的模拟方法来研究抗体可逆自我结合 (RSA).
为了阐明各种辅助剂在不同条件下对抗体RSA的影响.
根据长期的大规模模拟和实验数据验证模拟方法.

主要方法:

定位受限分子动力学模拟用于快速小规模分析抗体聚合.
模拟结果与长期 (>1μs) 和大规模 (>1,000,000个原子) 模拟结果进行比较.
集成与简单的稳定性表征和实验验证.

主要成果:

模拟准确地预测了辅助剂对单体残留含量和聚合趋势的影响.
在模拟中观察到的趋势与实验稳定性表征有很好的相关性.
基于模拟见解开发的配方经过实验验证.

结论:

拟议的模拟方法有效地揭示了抗体聚合机制和辅助剂相互作用.
模拟和实验结果显示了一致的趋势,增强了对蛋白质聚合的理解.
这种方法为生物制药配方研究提供了更快,更经济的替代方案.

关键词:

模拟MD的模拟方法两种特异性抗体的抗体蛋白质聚合蛋白质的聚合物单链片段变量的变量

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