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将介质干细胞及其外体研究转化为符合GMP的先进治疗产品:承诺,问题和前景

Chui-Yan Ma^1,2,3, Yuqing Zhai^1,2,3, Chung Tony Li^1,2

¹Center for Translational Stem Cell Biology, Hong Kong, China.

Medicinal research reviews

|December 14, 2023

概括

介质细胞干细胞 (MSCs) 显示出治疗前景,但面临临临床使用的质量控制挑战. 解决制造障碍和探索多能干细胞可以推进基于MSC的疗法.

科学领域:

干细胞生物学干细胞生物学
生物技术是生物技术.
再生医学是一种再生医学.

背景情况:

介质细胞干细胞 (MSC) 在临床环境中用于免疫调节和组织修复.
它们的治疗潜力源于近因子,分化能力,外体和线粒体捐赠.
目前的MSC应用经常使用骨髓或带衍生细胞.

研究的目的:

审查将MSC研究转化为制药产品的挑战和前景.
为了确定MSC和MSC外体的良好制造实践 (GMP) 合规性的障碍.
探索多能干细胞等替代细胞来源.

主要方法:

关于MSC翻译和GMP合规的当前文献的审查.
对原材料选择,细胞扩张,配方和质量控制 (QC) 的挑战进行分析.
讨论实时质量控制监控的自动化,封闭系统.

主要成果:

从不同来源保持一致的MSC质量存在重大挑战.
为MSC生产建立符合GMP的协议,需要对原材料,扩张,配方和质量控制给予密切关注.
建议使用自动化系统,以尽量减少人为错误和污染风险.

结论:

将MSC转化为先进治疗产品需要克服制造和质量控制的障碍.
标准化的GMP协议和强大的QC对于可靠的MSC治疗方法至关重要.
多能干细胞为MSC和外体细胞生成提供了一个有希望的替代方案.

关键词:

临床翻译临床翻译外基因组是外基因组的组成部分.良好的制造实践良好的制造实践介质细胞干细胞介质细胞干细胞治疗产品治疗产品.

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