高度单克隆抗体配方的度和血液溶解
Meng-Juan Pang1,2, Meng-Wen Wang3, Li-Fei Mao4
1Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, 310058, China.
Pharmaceutical research
|January 3, 2024
概括
缩单克隆抗体 (mAb) 配方的高透度不会影响产品的安全性. 这一发现支持使用更高的辅助剂水平来提高生物制药开发中的稳定性.
科学领域:
- 生物制药的发展.
- 蛋白质配方科学 蛋白质配方科学
- 药物输送系统是药物输送系统.
背景情况:
- 皮下单克隆抗体 (mAb) 配方越来越受青,以方便患者.
- 高度的mAb配方通常比通过结点压力 (FPD) 理论上预测的度更高.
- 在mAbs中这种度差异的安全影响尚未得到充分证实.
研究的目的:
- 调查缩的mAb配方中高度的安全性.
- 为了评估升高的度对红细胞完整性 (血液溶解) 的影响.
- 为了探索mAb度和测量的度之间的关系.
主要方法:
- 总结了FDA批准的高度mAb配方的理论度.
- 两种mAb配方 (150 mg/mL) 在理论计算的 (H) 和FPD测量的 (I) 同位素透率下制备.
- 进行了血液溶解实验,以比较H和I配方的安全性.
主要成果:
- 同一个mAb的H和I配方之间的血液溶解率是可比的.
- 测量的度随着mAb度的增加而线性增加.
- 缩的mAb配方中的高度没有诱导显著的血液溶解.
结论:
- 高度mAb配方中度升高不会影响产品的安全性.
- 辅助剂可以在更高的度中加入,以提高不稳定的mAb产品的稳定性.
- 这些发现支持开发稳定,缩的mAb配方用于皮下输送.
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