低场NMR作为PAT技术用于上游生物工艺监测的评估
Gabriella Gerzon1,2, Christian Fischer3, Matteo Pennestri4
1Department of Biology, Faculty of Science, York University, Toronto, Canada. gabyg@yorku.ca.
Pharmaceutical research
|February 19, 2026
概括
低场核磁共振 (LF NMR) 有效地监测了用于疫苗制造的上游细胞培养发酵. 这种方法提供了有价值的见解,补充近红外 (NIR) 光谱学,以增强过程的理解和控制.
科学领域:
- 生物技术是生物技术.
- 分析化学 分析化学
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 上游细胞培养发酵对于疫苗制造至关重要.
- 监测关键过程参数对于产品质量和产量的一致性至关重要.
- 传统方法可能缺乏实时流程优化所需的全面数据.
研究的目的:
- 评价低场核磁共振 (LF NMR) 用于监测上游细胞培养发酵.
- 评估LF NMR作为独立或直角方法与近红外光谱 (NIR) 一起进行.
- 确定LF NMR在疫苗生产中跟踪关键过程参数的能力.
主要方法:
- 从发酵样本获得离线NIR和LFNMR测量.
- 与参考数据和NIR数据进行比较分析和多变量建模.
- 使用LF NMR光谱和间接硬模型识别和量化代谢物.
主要成果:
- LF NMR准确量化了乳酸,葡萄糖和pH值,与离线和NIR方法有很好的一致性.
- 液脉核磁共振使得额外的代谢产物的识别和量化成为可能.
- 轻频NMR为NIR提供了补充信息,揭示了发酵参数的动态变化.
结论:
- 在疫苗制造中,LF NMR是监测细胞发酵的可行和有效工具.
- 轻频核磁共振作为一个有价值的独立或直角方法NIR.
- LF NMR提供了支持实时测量疫苗制造过程控制的见解.
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