通过使用玻璃状表面活性剂干燥实现的超高度生物疗法
Carolyn K Jons1, Alexander N Prossnitz1, Noah Eckman2
1Department of Materials Science and Engineering, Stanford University, Stanford, CA 94305, USA.
Science translational medicine
|August 20, 2025
概括
一种新型喷雾干燥蛋白质微粒平台使得超高度的生物制药配方可用于皮下注射. 这项技术提高了药物的稳定性和可注射性,有可能扩大患者获得关键蛋白质疗法的机会.
科学领域:
- 生物技术
- 材料科学
- 制药科学
背景情况:
- 像和抗体这样的生物制药是必不可少的,但容易聚合,限制有效性,并需要不方便的注射途径.
- 由于高度的稳定性问题,当前的蛋白质药物往往需要静脉输送,从而给患者带来负担.
- 迫切需要高度的生物制药配方,适合皮下注射,可自给药.
研究的目的:
- 为超高度生物制药配方开发一种新的可注射蛋白质输送平台.
- 使用独特的助剂和喷雾干燥技术提高生物制药的稳定性和可注射性.
- 为了证明皮下输送高剂量蛋白质治疗的可行性,提高患者的便利性.
主要方法:
- 使用新型聚烯胺衍生的共聚物辅料制成的喷雾干燥蛋白质微粒的输送平台的开发.
- 用于皮下注射的微粒悬浮在非溶剂载体中.
- 使用白蛋白,人体免疫球蛋白G和单克隆抗体评估配方稳定性,颗粒形态和可注射性.
- 在使用临床相关抗体药物的超高度时,对小鼠的药理动力学和疗效概况进行评估.
主要成果:
- 该平台允许超高度的蛋白质配方超过500mg/ml,可通过临床相关力的标准针进行注射.
- 这种新型辅助剂在喷雾干燥过程中改善了生物制药稳定性,并增强了颗粒性质,从而提高了注射性.
- 在临床前小鼠模型中,超高度配方可降低注射量而不会改变药理动力学或疗效.
- 已经证明成功制备和注射白蛋白,人体免疫球蛋白G和抗COVID单克隆抗体.
结论:
- 喷雾干燥的微粒平台为制造稳定,可注射,超高度的生物制药配方提供了有前途的方法.
- 这项技术显著提高了蛋白质药物的皮下注射潜力,解决了目前的输送方法的局限性.
- 这些发现表明,适用于皮下注射的蛋白质药物的数量可能增加近三倍,从而改善患者的获取和治疗负担.
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