生物制剂引起的组合产品中的耗
Fabian Moll1, Karoline Bechtold-Peters2, Wolfgang Friess1
1Pharmaceutical Technology and Biopharmaceutics, Department of Pharmacy, Ludwig-Maximilians-Universität München, 81377 Munich, Germany.
概括
预装注射器中的油迁移增加了挤出力,影响了容器的功能. 表面活性剂和特定单克隆抗体 (mAb) 等配方因素显著影响这种油脱落和容器稳定性.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 生物技术是生物技术.
背景情况:
- 从预装注射器 (PFS) 迁移油 (SO) 是生物制药组合产品的一个关键挑战.
- SO 耗尽增加了挤出力,可能会损害容器功能和药物输送.
研究的目的:
- 调查配方因子和单克隆抗体 (mAb) 特性对油迁移和喷雾化PFS滑动力的影响.
- 了解配方,蛋白质特性和储存期间容器稳定性之间的关系.
主要方法:
- 测试了不同配方 (表面活性剂类型,pH,离子强度) 和三个不同的mAbs的喷雾化PFS.
- 在2-8°C,25°C和40°C保存样品最长6个月,测量挤出力.
- 评估的界面张力 (IFT),界面形学,形状稳定性和mAb分子的疏水性.
主要成果:
- 由于SO分离,观察到挤出力显著增加,这取决于填充介质和储存温度 (特别是40°C).
- 表面活性剂的存在和类型是SO迁移趋势的主要驱动因素.
- 不同的mAbs对SO层稳定性表现出不同的影响,其中一个显示出IFT或风湿学无法解释的稳定作用.
结论:
- 药物产品的蛋白质成分 (mAb) 在油脱落和容器稳定性方面发挥着至关重要的作用.
- mAbs的疏水性与观察到的稳定性结果相关,这表明SO层相互作用的关键因素.
- 考虑辅助剂和特定蛋白质的配方优化对于确保生物制药PFS容器完整性至关重要.
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