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用实验室规模的设备扩大用于结核疫苗候选者的低温喷雾干燥工艺
Maximilian Aisenstat1, Joseph McCollum2, Mani Ordoubadi1
1Department of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
International journal of pharmaceutics
|March 12, 2025
概括
扩大实验室的喷雾干燥生物配方,如结核病 (TB) 疫苗,显著提高了生产率的十倍. 这一进步可以为关键的临床前研究生成更大的样本,而不会影响产品的稳定性.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 疫苗开发 疫苗开发
背景情况:
- 实验室规模的喷雾干燥对于开发干粉生物配方至关重要.
- 低温干燥是保持生物稳定的首选方法,但限制了生产速度.
- 从实验室规模的设备中生成足够的临床前研究材料是具有挑战性的.
研究的目的:
- 为了展示一个喷雾干燥辅助蛋白结核病 (TB) 疫苗候选人的扩展战略.
- 使用实验室规模的喷雾干燥设备增加生产吞吐量,而不损害粉末或生物稳定性.
- 制定疫苗粉末的一般制造指南.
主要方法:
- 使用定制实验室规模的喷雾干燥机扩大结核病疫苗候选人的规模.
- 采用一个过程模型来确定最佳的喷雾干燥参数.
- 专注于最大限度地提高干燥机的吞吐量和增加料度.
主要成果:
- 通过实验室规模的设备实现了生产率的十倍增长.
- 在一次6小时的运行中生产了97.6g的疫苗粉末 (相当于约5,000剂人体剂量).
- 在整个扩大规模的过程中保持粉末和生物材料的稳定性.
结论:
- 实验室规模的喷雾干燥可以有效地扩大规模,以增加生物配方的生产.
- 过程建模和参数优化是提高吞吐量,同时确保稳定的关键.
- 这种扩大规模的方法有助于产生大量的候选疫苗用于必要研究.
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