量化颗粒杂质对制药溶液冰核化行为的影响
Leif-Thore Deck1, Nikita Gusev1, Vasiliki Deligianni1
1Institute of Energy and Process Engineering, ETH Zurich, 8092 Zurich, Switzerland.
International journal of pharmaceutics
|January 4, 2025
概括
微粒杂质在生物制药中显著影响冰核化温度,影响冷和冷干燥过程. 控制颗粒物对于一致的制药生产至关重要.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 物理化学 物理化学
- 生物加工是一种生物加工.
背景情况:
- 生物制药通常存储在冷或冷干燥的瓶中.
- 冰核化温度和分布对于工艺设计至关重要.
- 微粒杂质是制药制造中的一个关键参数.
研究的目的:
- 在生物制药配方中实验性地研究颗粒杂质对冰核形成行为的影响.
- 了解不同的颗粒物水平如何影响核化温度和变异性.
- 评估这些发现对工业生物制药加工的相关性.
主要方法:
- 在无颗粒和标准实验室条件下准备样品.
- 控制添加银化物颗粒,以评估它们的影响.
- 实验测量冰核化温度和变异性的测量.
- 在病毒载体疫苗和单克隆抗体 (mAb) 中核化行为的评估.
主要成果:
- 与标准样本相比,无颗粒物样本的核化温度较低,变化更大.
- 添加化银颗粒导致了更高和更不变的核化温度.
- 在测试的生物制药 (病毒载体疫苗和mAb) 之间观察到核化行为的显著差异.
结论:
- 在工业相关条件下,颗粒杂质的含量显然会影响冰的核化速率.
- 生物制药配方显示出由颗粒物影响的独特的冰核化行为.
- 在生物制药的工艺设计过程中,测量冰核化行为至关重要.
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