使用拉曼光谱学实时监测减弱型细胞巨型病毒,可以在流动过程中进行非破坏性表征
Shreya Milind Athalye1, Murali K Maruthamuthu2, Ehsan Esmaili3
1Department of Agricultural and Biological Engineering, Purdue University, West Lafayette, IN 47907, USA; Birck Nanotechnology Center, Purdue University, West Lafayette, IN 47907, USA; Bindley Bioscience Center, Purdue University, West Lafayette, IN 47907, USA.
概括
这项研究引入了拉曼光谱工具,用于实时监测疫苗制造中的病毒颗粒. 非侵入性技术准确量化病毒颗粒,即使在高流速,确保质量控制.
科学领域:
- 生物技术是生物技术.
- 分析化学 分析化学
- 频谱学是一种光谱学.
背景情况:
- 实时监测病毒颗粒对于疫苗制造和公共卫生至关重要.
- 像拉曼光谱学这样的光谱学方法提供了快速,非侵入性的测量能力.
研究的目的:
- 开发和描述基于拉曼光谱的工具,用于在连续流设置中监测病毒颗粒的质量和数量.
- 评估该工具在各种度和减弱的人类细胞巨核病毒 (CMV) 流速方面的性能.
主要方法:
- 使用拉曼光谱在一个连续流系统与一个方形石英毛细管.
- 具有特征的减弱的人类细胞巨乳病毒 (CMV) 度从1.45 × 10^10到2.90 × 10^11颗粒/毫升,流速从100到1000微米/秒.
- 使用SDS-PAGE和激光暴露后动态光散射 (DLS) 验证样品完整性.
主要成果:
- 拉曼光谱仪成功监测了连续流量设置中的病毒颗粒,即使在高流速 (1000微米/秒) 中也是如此.
- 在1000μm/s时,证明了CMV的检测极限 (LODmin) 为2.01 × 10^10颗粒/毫升.
- 证实激光暴露不会损害病毒颗粒的完整性,验证了该方法的非侵入性.
结论:
- 拉曼光谱是一种可行的过程分析技术 (PAT),用于实时监测生物制造中的病毒颗粒.
- 这项技术通过确保病毒颗粒的质量和数量,使疫苗生产的有效过程控制成为可能.
- 这项研究代表了使用拉曼光谱在流量条件下的CMV粒子的首次表征.
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