活塞插入和化方法对抗体配方颗粒形成的协同效应
Alexandra Lucas1, Angelina Bespalova2, Vaibhav Upadhyay1
1Center for Pharmaceutical Biotechnology, Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, 12850 East Montview Blvd, MS C238-V20, Aurora, CO 80045, United States.
Journal of pharmaceutical sciences
|October 18, 2025
概括
预装注射器具有交联涂层和机械插入,显示较少的蛋白质聚合物和颗粒. 这种方法提高了药物产品的质量和蛋白质疗法患者的安全性.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 药物输送系统 药物输送系统
背景情况:
- 预填注射器是蛋白质疗法的标准,提供临床和经济优势.
- 注射器中的油滑剂可能会泄漏,导致蛋白质聚合和颗粒形成,损害药物的安全性和有效性.
研究的目的:
- 用不同的化和插入方法评估预填注射器中的颗粒形成和蛋白质聚合.
- 确定最佳实践,以尽量减少颗粒的形成,并保持抗体配方中的蛋白质稳定性.
主要方法:
- 使用微流成像,光遮蔽,SEC,MALS和AUC评估的颗粒含量和蛋白质聚合.
- 研究了热和机械应力对各种化和插入配对制备的注射器的影响.
主要成果:
- 带有交联涂层和机械插入的注射器显示颗粒度显著降低.
- 与真空插入或喷涂化相比,优化的方法最大限度地减少了蛋白质聚合.
结论:
- 冲压器插入和化方法在填充/完成过程中对蛋白质聚合物的形成有协同作用.
- 优化预填注射器制备对于保持蛋白质治疗质量,安全性和有效性至关重要.
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