Strategies for scalable manufacturing and translation of MSC-derived extracellular vesicles
Strategies for scalable manufacturing and translation of MSC-derived extracellular vesicles
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DOI：
10.1016/j.scr.2020.101978
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发表时间：
2020-10-01
影响因子：
1.2
通讯作者：
Ahsan, Tabassum
中科院分区：
文献类型：
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作者：
Adlerz, Katrina;Patel, Divya;Ahsan, Tabassum
骨髓间充质干细胞(MSCs)是一种研究广泛的细胞疗法，在过去的几十年里进行了许多临床试验，以治疗一系列的治疗适应症。最近，间充质干细胞分泌的胞外小泡(MSC-EVS)已被证明具有MSCs本身的许多治疗作用。虽然对MSC-EVS的研究已经爆炸式增长，但它们仍处于临床治疗的早期发展阶段。细胞疗法的主要挑战之一是开发一种可扩展的、与cGMP兼容的制造范例，这显然也将是MSC-EV制造中的一个挑战。因此，这篇综述的重点是确定一些关键的MSC-EV制造考虑因素，如关键原材料的选择、制造平台和关键质量属性分析。在研究和开发早期解决这些问题将加快MSC-EVS的临床产品开发、临床试验和商业治疗。
Mesenchymal Stem/Stromal Cells (MSCs) are a well-studied cellular therapy with many clinical trials over the last few decades to treat a range of therapeutic indications. Recently, extracellular vesicles secreted by MSCs (MSC-EVs) have been shown to recapitulate many of the therapeutic effects of the MSCs themselves. While research in MSC-EVs has exploded, it is still early in their development towards a clinical therapy. One of the main challenges in cellular therapy, which will clearly also be a challenge in MSC-EV manufacturing, is developing a scalable, cGMP-compatible manufacturing paradigm. Therefore, the focus of this review is to identify some key MSC-EV manufacturing considerations such as the selection of critical raw materials, manufacturing platforms, and critical quality attribute assays. Addressing these issues early in research and development will accelerate clinical product development, clinical trials, and commercial therapies of MSC-EVs.