相互动期间的剪切流不会破坏固体-液体接口上的蛋白质膜
Tetsuo Torisu1, Nana Iwamoto1, Rio Okada1
1Department of Biotechnology, Graduate School of Engineering, The University of Osaka, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan.
International journal of pharmaceutics
|March 2, 2026
概括
震动导致蛋白质聚合主要发生在空气-液体接口上,而不是在瓶子表面. 这项研究澄清了接口作用,帮助生物制药配方和工艺设计,以防止蛋白质聚合.
科学领域:
- 生物制药的发展.
- 蛋白质科学是一种蛋白质科学.
- 化学工程是化学工程的组成部分.
背景情况:
- 蛋白质聚合是生物制药制造中的一个重大障碍.
- 机械应力,如震动,通过接口诱导聚合.
- 空气-液体,固体-液体和空气-液体-固体接口在震动诱导聚合中的特定作用尚未完全理解.
研究的目的:
- 系统地研究个人接口对动过程中蛋白质聚合的贡献.
- 为了区分固体-液体接口切割流与其他接口的影响.
主要方法:
- 计算流体动力学 (CFD) 在动过程中模拟了小瓶表面的剪切速率.
- 有控制的实验将剪流应用于缓冲中的蛋白质涂层玻璃瓶 (消除空气-液体接口).
- 使用头部空间的震动实验评估了空气-液体-固体接口贡献.
主要成果:
- 在剪切流条件下,在固体-液体界面上没有观察到显著的蛋白质聚合增加.
- 空气-液体-固体接口对蛋白质聚合没有可测量的贡献.
- 空气-液体接口被确定为动过程中蛋白质聚合的主要驱动因素.
结论:
- 空气-液体接口是震动诱导蛋白质聚合的主要因素.
- 固体-液体剪切流在破坏蛋白膜和引起聚合方面起的作用很小.
- 研究结果为优化生物制药配方和处理提供了关键的见解,以最大限度地减少聚合.
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