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深入研究旋转标记聚酸盐与治疗抗体的相互作用,使用二维NMR,EPR和MD模拟

Blaž Lebar¹, Maria Orehova², Boštjan Japelj³

¹University of Ljubljana, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, Aškerčeva 7, SI-1000 Ljubljana, Slovenia; Novartis Pharmaceutical Manufacturing LLC, Kolodvorska 27, SI-1234 Menges, Slovenia.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|October 11, 2025

概括

聚酸盐 (PS) 在生物制药中至关重要,但会降解. 这项研究使用先进的NMR和EPR发现了单克隆抗体 (mAbs) 和PS之间的弱相互作用,揭示了mAbs如何保护这些重要的表面活性剂.

科学领域:

生物制药配方生物制药配方
蛋白质稳定蛋白质稳定
表面活性剂的降解降解

背景情况:

聚酸盐 (PS) 是生物制药中必不可少的辅助成分,防止蛋白质聚合和变性.
聚氨酸的降解会导致有害颗粒的形成,从而损害药物的安全性和有效性.
有证据表明单克隆抗体 (mAbs) 可能会影响PS稳定性,暗示直接相互作用.

研究的目的:

研究单克隆抗体 (mAbs) 和多酸盐 (PS) 之间的相互作用.
了解mAbs可以减轻PS降解的机制.
描述生物制药配方中蛋白质-表面活性剂相互作用的性质和强度.

主要方法:

超磁性放松增强 (PRE) NMR使用自旋标记聚酸盐 (SLPS).
¹H T₂ CPMG 的过器实验和甲基指纹检测.
电子偏磁共振 (EPR) 光谱学.电子偏磁共振 (EPR) 光谱学.
分子动力学 (MD) 模拟.分子动力学 (MD) 模拟.

主要成果:

标准的NMR技术未能检测到mAbs和PS之间的相互作用.
PRE NMR和EPR成功检测到SLPS和mAbs之间的弱,短暂的相互作用,特别是在糖糖的存在下.
在MD模拟中,在mAb表面上发现了潜在的相互作用点.

结论:

需要先进的NMR和EPR技术来检测弱蛋白-表面活性剂相互作用.
单克隆抗体与多酸盐暂时相互作用,可能有助于它们的稳定.
了解这些相互作用为优化生物制药配方提供了机制性见解.

关键词:

电子的偏磁共振是一种超磁共振.互动互动互动互动分子动力学分子动力学一个单克隆抗体的抗体.核磁共振是一种核磁共振.聚酸盐是一种多酸盐.

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