快速室温气溶脱水与喷雾干燥:生物制药干燥技术的新范式
Sadegh Poozesh1, Maksim Mezhericher2, Zehao Pan2
1Dosage Form Design and Development, BioPharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, Maryland 20878, USA.
Journal of pharmaceutical sciences
|October 6, 2023
概括
一种新的气溶辅助干燥方法比生物制药生产的喷雾干燥更好地保持生物完整性. 这种新的技术为先进的药物输送提供了更好的蛋白质质量和气溶性能.
科学领域:
- 生物制药制造业 生物制药制造业
- 蛋白质配方科学 蛋白质配方科学
- 用于药物输送的粒子工程.
背景情况:
- 软化是生物制药干燥的标准,但喷雾干燥为肺部管理提供了粒子工程的好处.
- 在喷雾干燥过程中保持生物完整性仍然是生物制药行业面临的重大挑战.
研究的目的:
- 评估一种新的气溶辅助室温干燥系统,即室温气溶快速脱水 (RR-TAD),用于生物制药生产.
- 将RR-TAD生产的生物制药粉末的质量属性与传统喷雾干燥进行比较.
主要方法:
- 碎片抗原结合 (Fab) 配方使用RR-TAD和喷雾干燥进行处理.
- 对于产生的散装粉末,评估了质量属性,包括蛋白质降解和气溶性能.
主要成果:
- 在所有测试的Fab配方中,RR-TAD方法表明产品质量优于喷雾干燥.
- RR-TAD导致蛋白质降解减少和提高气溶性能.
结论:
- 快速室温气溶脱水 (RR-TAD) 为保持生物制药的完整性提供了喷雾干燥的有希望的替代方案.
- 这种新的脱水技术有可能提高生物制药产品的质量并扩大生产可能性.
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