The use of human mesenchymal stem/stromal cells (hMSC) in clinical trials has been exponentially increasing over the last decade. To meet the high-growth demand for high quality hMSC products, much research and many reports have been published on bioprocess development for hMSC production in bioreactors, their downstream processing and on the development of analytical tools for standardization and harmonization of functional assays to assess hMSC potency. Here we discuss the last advances in hMSC manufacturing that have been designed through a better understanding of the attributes critical for assuring product quality, safety and therapeutic efficacy.

在过去的十年中，人间充质干/基质细胞（hMSC）在临床试验中的使用呈指数增长。为了满足对高质量hMSC产品的高增长需求，关于生物反应器中hMSC生产的生物工艺开发，其下游加工以及用于评估hMSC的功能测定的标准化和协调性分析工具的开发，已经发表了许多研究和许多报告。效力。在这里，我们讨论了hMSC生产中的最新进展，这些进展是通过对确保产品质量，安全性和治疗功效的关键属性的更好理解而设计的。