Manufacturing Exosomes: A Promising Therapeutic Platform. Issue 3 (March 2018) - Colao, Ivano Luigi
Abstract : 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. Highlights: Exosome research has been rejuvenated in recent years, due in part to the evolution in understanding of stem cell mode of action. The paracrine effect of stem cell therapy candidates has been mechanistically linked to inherited, specific functionality in secreted exosome derivatives. Even though exosomes are expected to enter clinical trials imminently, there has been a lack of manufacturing process development work that is needed to generate clinically relevant quantities of exosomes as trials progress towards larger patient numbers. If manufacturing research is not undertaken now, then the advancement of exosomes as a new therapeutic platform will be slowed. Thus, there is an urgent need for technological advancements. Here, we present process options for industrial and academic researchers to consider to translate exosomes into viable therapeutic candidates from a manufacturing perspective.