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在CART细胞生产过程中检测无采样细菌污染的白光光谱:走向线上和实时系统
Bruno Wacogne1,2, Naïs Vaccari1, Claudia Koubevi1
1CNRS, Institut FEMTO-ST, Université Marie et Louis Pasteur, 25000 Besançon, France.
Biosensors
|August 27, 2025
概括
一种新的白光光谱法检测了先进治疗药物 (ATMP) 生产中的污染. 这种实时的非采样技术可以降低药物成本并改善患者的可用性.
科学领域:
- 生物技术
- 分析化学
- 制药业 制造业
背景情况:
- 先进治疗药物 (ATMP),特别是那些使用转基因T细胞治疗癌症的药物,价格昂贵.
- 在ATMP生产过程中的污染是一个重大问题,传统的采样方法可能会带来进一步的污染.
- 目前的ATMP质量控制方法耗时,不允许实时监控.
研究的目的:
- 开发一种非采样,实时的方法来检测ATMP生产中的污染.
- 通过更快地检测和停止受污染的批次来降低ATMP的成本.
- 提高救命的ATMP疗法的可用性.
主要方法:
- 开发一种白光光谱技术.
- 对吸收光谱形状的分析,特别是从高斯形状过渡到受细菌吸收光谱 (1/λ组件) 的影响.
- 实施形状描述符和污染检测的警告值.
主要成果:
- 白光光谱法成功检测了ATMP生产中的污染.
- 污染可以在几个小时内被发现, 允许快速干预.
- 该方法广泛适用于具有明显光谱特征的各种污染物.
结论:
- 白光光谱为ATMP制造中的实时污染监测提供了一种新的非侵入性方法.
- 这种方法有可能显著降低生产成本并提高先进疗法的可用性.
- 通过光谱形状分析及早检测可确保产品的安全性和有效性.
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