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在CAR-T细胞治疗中快速普遍检测高风险和低丰度的微生物污染

Xiaolin Wu¹, Joshua Jebaraj Raymond¹, Yaoping Liu^1,2

¹Critical Analytics for Manufacturing Personalized Medicine Interdisciplinary Research Group, Singapore-MIT Alliance for Research and Technology Centre (SMART-CAMP), Singapore, 138602, Singapore.

|March 31, 2025

概括

对于细胞疗法而言,快速无菌性测试至关重要. 一个新的工作流程使用数字循环介导的同热放大 (dLAMP) 与静电微过 (EM) 来在6小时内检测CAR-T细胞培养物中的微生物污染.

科学领域:

生物技术是生物技术.
微生物学微生物学
细胞疗法制造业细胞疗法制造业

背景情况:

活微生物污染对细胞和基因疗法构成重大风险.
目前的不育测试方法耗时,延迟制造和患者安全评估.
迫切需要在复杂的细胞培养环境中快速,敏感地检测微生物.

研究的目的:

开发一种创新,快速和灵敏的工作流程,用于细胞和基因治疗产品的无菌性测试.
为了实现制造过程的实时监控和CAR-T电池产品的及时安全评估.

主要方法:

开发一个采样到结果的工作流程,集成数字循环介导的同热放大 (dLAMP) 和基于静电微过 (EM) 的丰富.
设计针对16S和18SrRNA的通用和菌株特异性原料,用于广泛的细菌和真菌检测.
在CAR-T细胞中从微生物溶解物直接分析消耗的介质和最终产品.

主要成果:

工作流程在6小时内在复杂的CAR-T细胞培养物中检测到低至1CFU/mL的污染.
dLAMP测定使已知微生物物种的80%以上的普遍检测和菌株特定识别成为可能.
与qPCR和14天综合方法相比,证明了更高的准确性和显著更快的周转时间.

结论:

增强EM的dLAMP工作流提供了一个快速,灵敏和准确的解决方案,用于细胞疗法制造中的无菌性测试.
这种方法在实时过程监测和CAR-T细胞产品的输注前安全性评估方面具有变革性的潜力.
工作流程广泛适用于传染病诊断,生物制造,食品安全和环境监测.

关键词:

细胞治疗无菌性测试数字LAMP是一个数字LAMP.电静电微过的微过方法多重核酸测试多重核酸测试对病原体的定量检测.

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