间充质干细胞/基质细胞衍生外泌体的潜在药用性

Fan Zhang, Leisheng Zhang, Hao Yu
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引用次数: 0

摘要

间充质干细胞/基质细胞(MSC-Exos)分泌的外泌体是新型细胞疗法的有利候选来源。尽管目前有良好生产规范(GMP)标准,但由于缺乏合适的质量控制方法以及大规模制备的困难,在很大程度上限制了治疗产品的开发及其在全球范围内的临床应用。在此,我们主要从企业角度出发,探讨外泌体 GMP 中常见的三个主要问题,包括细胞培养过程的上游问题、纯化过程的下游问题、外泌体质量控制以及外泌体的药物特性及其可药用性。总之,在这篇综述文章中,我们提出了制备临床外泌体药物治疗多种疾病的问题,为 GMP 级间叶干细胞-外泌体的临床应用提供了新的参考。
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Potential Druggability of Mesenchymal Stem/Stromal Cell-derived Exosomes.

Exosomes secreted by mesenchymal stem/stromal cells (MSC-Exos) are advantageous candidate sources for novel acellular therapy. Despite the current standards of good manufacturing practice (GMP), the deficiency of suitable quality-control methods and the difficulties in large-scale preparation largely restrict the development of therapeutic products and their clinical applications worldwide. Herein, we mainly focus on three dominating issues commonly encountered in exosomal GMP, including issues upstream of the cell culture process, downstream of the purification process, exosomes quality control, and the drug properties of exosomes and their druggability from a corporate perspective. Collectively, in this review article, we put forward the issues of preparing clinical exosome drugs for the treatment of diverse diseases and provide new references for the clinical application of GMP-grade MSC-Exos.

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