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开发一种符合GMP的实用制造工艺,用于T细胞衍生的诱导多能干细胞

Ruud Hulspas¹, Carolina Sasso², Amy Cunningham²

¹Connell & O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Smith Research Building, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.

|February 15, 2026

概括

这项研究详细介绍了一种符合GMP的工作流程,用于从T细胞生成自主诱导多能干细胞 (iPSC),产生13个临床可行的iPSC线条,并优化了对转化应用的制造.

科学领域:

干细胞生物学干细胞生物学
细胞重编程细胞重编程
良好的制造实践 (GMP) 是一个

背景情况:

自主诱导多能干细胞 (iPSCs) 对再生医学具有前景.
建立符合GMP的制造工作流程对于临床翻译至关重要.
重编程周围血液单核细胞 (PBMCs) 为iPSC生成提供了一个可行的来源.

研究的目的:

开发和验证一个符合GMP的制造工作流程,用于从T细胞生成自身的iPSC.
评估生成的iPSC的质量,身份和基因组完整性.
优化工作流程,以提高临床环境中的效率和可重复性.

主要方法:

使用GMP级仙台病毒载体对T细胞丰富的PBMC进行重新编程.
对于多能性标记物 (Oct-4,TRA-1-60,SSEA-1) 的 iPSC 殖民地的表征.
通过T细胞受体 (TCR) β链基因重组分析确认T细胞起源.
细胞遗传学分析 (G带胆型定型) 和针对性测序 (OncoPanel测定) 来检测基因组完整性.
实现过程暂停,以优化工作流程.

主要成果:

产生20个具有高多能性标志物表达的iPSC殖民地.
在18/20个iPSC线路中确认T细胞起源,其中有14个独特的克隆上不同的线路.
在T细胞衍生的iPSC中发现复发的PRSS1基因缺失,该缺失也存在于供体T细胞中.
获得了13个独特的T细胞衍生的iPSC线,符合所有质量控制和释放标准.
证明了工作流的优化策略,以提高运营效率.

结论:

成功建立了一种符合GMP的实用工作流程,用于自身T细胞衍生的iPSC生成.
生成的iPSC线路适用于下游临床和转化应用.
工作流的优化提高了iPSC制造在临床环境中的可行性和可重复性.

关键词:

T细胞受体受体的 T 细胞受体.在T细胞,T细胞.cGMP的良好使用情况.临床级别的临床级别.这就是 iPSC 的意义.制造业制造业是一个制造业.

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