揭示过,过程中断和过程后刺激对蛋白质聚合的影响
Christina Winter1, Anna Springer1, Jean-Loup Descamps2
1Research Center Pharmaceutical Engineering Gmbh, Graz, Austria.
AAPS PharmSciTech
|March 15, 2025
概括
在生物制药过过程中蛋白质聚合是一个关键问题. 这项研究研究了不同过材料 (PVDF,PES,CA) 如何影响颗粒形成和糖蛋白结构变化,为选择最佳过过程提供了洞察力.
科学领域:
- 生物制药制造业 生物制药制造业
- 过技术过技术的使用
- 蛋白质化学 蛋白质化学
背景情况:
- 无菌过对于生物制药制造至关重要,通常使用0.22μm膜过器.
- 蛋白质与过器的相互作用和颗粒脱落可能导致聚合,对肠道应用构成风险.
- 了解波器材料的影响对于预防免疫反应至关重要.
研究的目的:
- 在过过程中调查糖蛋白配方中的颗粒形成和结构变化.
- 评估不同水友膜材料 (PVDF,PES,CA) 对过性能的影响.
- 在各种压力条件下评估波器的行为,包括恒定/脉冲过,和加热.
主要方法:
- 使用PVDF,PES和CA膜过器 (0.22μm孔径) 进行了恒定和冲动过实验.
- 分析了颗粒形成 (可见,次可见,次微米) 和糖蛋白结构变化.
- 过器经过和加热,以模拟诱导聚合的条件.
主要成果:
- 不同的过材料表现出不同程度的颗粒形成和对糖蛋白结构的影响.
- 过方法 (恒定与冲动) 影响了蛋白质聚合和过性能.
- 高初始颗粒含量和压力条件影响过器行为和蛋白质完整性.
结论:
- 过材料的选择显著影响生物制药过过程中的蛋白质聚合和颗粒生成.
- 必须仔细考虑过过程设计,包括流动动力学和压力因素,以尽量减少蛋白质聚合.
- 结果为优化无菌过策略提供了关键数据,以确保生物制药的安全性和有效性.
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