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.

间充质干细胞/间质干细胞（MSCs）是一项经过充分研究的细胞疗法，在过去的几十年中进行了许多临床试验，以治疗一系列治疗适应症。近来，已经显示出由MSC（MSC-EV）分泌的细胞外囊泡概括了MSC本身的许多治疗作用。尽管MSC-EV的研究激增，但仍朝着临床疗法发展。细胞疗法的主要挑战之一，显然也将是MSC-EV制造中的挑战，正在开发一种可扩展的，兼容cGMP的制造范例。因此，这次审查的重点是确定一些关键的MSC-EV制造注意事项，例如关键原材料的选择，制造平台和关键质量属性分析。