如何喷雾干燥处理和溶液组成可以影响 mAbs 溶液中的稳定性. 第二部分:探索每一种蛋白质稳定剂效应
Carla M Barcelo-Chong1, Vasco Filipe2, Mostafa Nakach2
1IMT Mines Albi, RAPSODEE UMR CNRS 5302, Albi, France.
International journal of pharmaceutics
|March 21, 2024
概括
喷雾干燥生物制药,如单克隆抗体 (mAbs),需要谨慎的配方. 辅助剂,特别是表面活性剂,显著提高了在复制溶液中喷雾干燥的mAbs的稳定性.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 化学工程是化学工程的重要组成部分.
背景情况:
- 喷雾干燥是一种广泛用于生物制药配方的技术.
- 然而,该过程可能会引起影响蛋白质稳定性的压力.
- 优化配方成分和工艺条件对于稳定的喷雾干燥生物制药至关重要.
研究的目的:
- 研究喷雾干燥处理和溶液成分对单克隆抗体 (mAb) 稳定性的影响.
- 为了确定辅助剂和蛋白质度在喷雾干燥过程中对mAb稳定性的影响.
- 为了确定稳定,喷雾干燥的mAb粉末用于皮下注射的最佳配方策略.
主要方法:
- 分离工艺应力 (剪切,热/脱水) 以评估个别压力因素的影响.
- mAb-A度和辅助剂类型 (糖,氨基酸,表面活性剂) 和度的系统变化.
- 对复制的喷雾干燥的mAb-A粉末进行聚合和度分析.
主要成果:
- 发现助剂和蛋白质度对稳定mAb-A比喷雾干燥操作条件更为关键.
- 辅助剂的度增加,特别是表面活性剂,与减少聚合和度相关.
- 确定了一种合适的配方成分,以确保喷雾干燥的mAb-A.的稳定性.
结论:
- 配方成分,特别是辅助剂的类型和度,在喷雾干燥过程中稳定mAbs中起着关键作用.
- 表面活性剂在缓解复制喷雾干燥的mAb粉末中的聚合和度方面特别有效.
- 这些发现推动了用于皮下注射的稳定有效药物配方的开发.
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