喷雾干燥过程的挑战和考虑吸入的生物制剂的考虑.
Sadegh Poozesh1, Patrick Connaughton2, Scott Sides2
1Dosage Form Design & Development, Biopharmaceuticals Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
喷雾干燥为吸入的生物制剂提供了优势,但蛋白质降解和工艺扩展方面的挑战需要谨慎管理. 本综述详细介绍了从准备到处理粉末的喷雾干燥优化策略.
科学领域:
- 制药技术 制药技术 制药技术
- 生物加工是一种生物加工.
- 材料科学 材料科学 材料科学
背景情况:
- 由于受控颗粒属性,喷雾干燥有利于生产吸入的生物制剂.
- 解决端到端喷雾干燥过程中的挑战对于利用其好处至关重要.
研究的目的:
- 为生物制剂的喷雾干燥挑战提供全面的概述,重点关注蛋白质降解.
- 描述整个喷雾干燥过程,包括制备,干燥和粉末处理.
- 检查扩大规模的瓶,并提出行业相关的缓解策略.
主要方法:
- 关于生物制剂喷雾干燥的文献综述.
- 分析蛋白质降解机制和评估工具.
- 检查工艺阶段:料溶液的制备,喷雾干燥和散装粉末的处理.
- 讨论扩大规模的挑战和控制战略.
主要成果:
- 喷雾干燥为吸入的生物制剂提供了微调的粒子属性.
- 蛋白质降解是一个关键的挑战,已经确定了各种机制.
- 扩大规模存在重大瓶,需要具体的缓解策略.
- 分析工具对于评估蛋白质完整性和气溶性能至关重要.
结论:
- 生物制剂的成功喷雾干燥需要解决蛋白质降解和过程控制方面的挑战.
- 与行业相关的策略可以在扩展期间减轻风险.
- 新兴趋势可能会增强未来的生物制品喷雾干燥技术.
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