Extracellular vesicles, in particular the subclass exosomes, are rapidly emerging as a novel therapeutic platform. However, currently very few clinical validation studies and no clearly defined manufacturing process exist. As exosomes progress towards the clinic for treatment of a vast array of diseases, it is important to define the engineering basis for their manufacture early in the development cycle to ensure they can be produced cost-effectively at the appropriate scale. We hypothesize that transitioning to defined manufacturing platforms will increase consistency of the exosome product and improve their clinical advancement as a new therapeutic tool. We present manufacturing technologies and strategies that are being implemented and consider their application for the transition from bench-scale to clinical production of exosomes.

细胞外囊泡，特别是亚类外泌体，正在迅速发展为一种新型治疗平台。但是，目前很少有临床验证研究，也没有明确定义的制造过程。随着外泌体进入临床治疗多种疾病的过程，重要的是在开发周期的早期确定其制造的工程基础，以确保可以在适当的规模上经济高效地生产它们。我们假设过渡到定义的制造平台将增加外泌体产品的一致性，并改善其作为新的治疗工具的临床进展。我们介绍正在实施的制造技术和策略，并考虑其在从实验室规模向外泌体临床生产过渡中的应用。