在静脉注射抗体药物稀释期间,注射器处理中蛋白质聚合的潜在危险因素
Masakazu Fukuda1, Shino Nagae1, Toru Takarada1
1Laboratory of Functional Molecular Chemistry, Kobe Pharmaceutical University, 4-19-1, Motoyamakita-machi, Higashinada-ku, Kobe 658-8558, Japan.
Journal of pharmaceutical sciences
|January 25, 2025
概括
在静脉注射稀释期间处理注射器可以加速生物制药中的蛋白质聚合. 高切削应力和活塞使用增加了颗粒的形成,危及治疗稳定性,特别是在高稀释条件下.
科学领域:
- 生物制药品质量控制的质量控制
- 在临床处理期间蛋白质的稳定性.
- 抗体聚合机制 抗体聚合机制
背景情况:
- 蛋白质聚合是生物制药制造和质量控制中的一个关键问题.
- 临床处理程序,如静脉注射,可以引入加速蛋白质聚合的压力.
- 了解这些压力对于保持抗体疗法的有效性和安全性至关重要.
研究的目的:
- 为了研究在稀释过程中注射器处理对蛋白质聚合的影响.
- 在注射器使用中识别导致蛋白质聚合的特定因素.
- 评估聚酸盐20在缓解注射器诱导聚合物的有效性.
主要方法:
- 使用马球蛋白和IgG溶液作为模型抗体疗法.
- 研究了在注射器稀释过程中高滑动速度和活塞操作的影响.
- 在各种条件下评估了可见和可见的蛋白质颗粒的形成.
主要成果:
- 较高的滑动速度和活塞操作显著增加了蛋白质聚合和颗粒形成.
- 蛋白质颗粒的形成与在针穿过时由剪切应力产生的气泡有关.
- 聚酸盐20减轻了聚合,但在高稀释条件下效果较差.
结论:
- 注射器处理和稀释条件是临床使用期间生物制药聚合的重要风险因素.
- 配方策略和处理协议需要优化以确保蛋白质的稳定性.
- 需要进一步的研究来开发强大的生物制药配方和更安全的临床实践.
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