治疗单克隆抗体的稳定性在注射用于家庭治疗的弹性体时
Elham Taherian1, Mirjam Crul2, Reza Nejadnik1
1Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, Iowa City, Iowa, 52242, United States.
Journal of pharmaceutical sciences
|January 12, 2026
概括
单克隆抗体 (mAbs) 在通过弹性给药时表现出稳定性,支持家庭输液. 这项研究证实 cetuximab 和 trastuzumab 没有聚合或降解,验证了这些生物制剂的使用.
科学领域:
- 生物制药药物药物输送
- 蛋白质疗法稳定性 蛋白质疗法稳定性
- 生物技术和制药配方 生物技术和制药配方
背景情况:
- 单克隆抗体 (mAbs) 通常在医院内静脉注射.
- 家庭疗法正在增加,需要稳定的药物输送设备.
- 弹性体适合家庭使用,但需要像mAbs.等敏感生物的稳定性数据.
研究的目的:
- 为了评估在弹性输液过程中销售的单克隆抗体 (mAbs) 的稳定性.
- 评估 cetuximab 和 trastuzumab 在弹性中的潜在聚合和颗粒形成.
- 为使用弹性提供mAbs在家用药物的稳定性数据.
主要方法:
- 高性能尺寸排除色谱 (HPSEC) 用于聚合分析.
- 流成像显微镜 (FIM) 用于量化可见的微粒.
- 动态光散射 (DLS) 和纳米粒子跟踪分析 (NTA) 用于粒子大小分布.
主要成果:
- HPSEC证实抗体没有聚合或降解.
- 在注入之前和之后,FIM显示出一致的颗粒数量.
- DLS和NTA表示均的颗粒大小,没有可检测的聚合.
结论:
- 弹性体在技术上是可行的,可以在不影响稳定性的情况下给药塞图西马布和特拉斯图祖马布.
- 这项研究提供了支持使用弹性用于家庭 mAb 治疗的关键数据.
- 研究结果表明,产品稳定性可以在传统医院环境之外保持.
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