Department of Biochemical Engineering, University College London, Gower St, London, WC1E 6BT, UK.
ReNeuron, Pencoed Business Park, Pencoed, Bridgend, CF35 5HY, UK.
Trends Mol Med. 2018 Mar;24(3):242-256. doi: 10.1016/j.molmed.2018.01.006. Epub 2018 Feb 12.
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，特别是外泌体亚类，正在迅速成为一种新的治疗平台。然而，目前几乎没有临床验证研究，也没有明确界定的制造工艺。随着外泌体在临床上治疗各种疾病的进展，在开发周期的早期确定其制造的工程基础非常重要，以确保能够以适当的规模经济高效地生产。我们假设向明确的制造平台过渡将提高外泌体产品的一致性，并改善其作为新型治疗工具的临床进展。我们介绍了正在实施的制造技术和策略，并考虑了它们在从实验室规模到临床生产外泌体的过渡中的应用。
