Process development for recovery and purification of exosomes for regenerative therapy

外切体正在成为一种新的治疗候选药物，具有治疗多种适应症的潜力。ReNeuron和UCL在外显体制造领域有着良好的合作记录，我们通过Innovate UK赠款和现有的EngD项目在制造外显体方面取得了重大进展。然而，尽管我们已经探索了回收和纯化外切体的方案，并在上游细胞培养方面取得了重大进展，但仍需努力提高特定外切体亚群的纯度，并对所产生的产物进行有意义的测量。在伦敦大学学院已经开发的去除工艺杂质的色谱方法的基础上，我们将通过增强抛光和新的数量和质量测量，进一步朝着获得监管部门批准的产品迈进。具体地说，我们的目标是改进纯化技术和测量工具，以从干细胞中高纯度地回收外体亚群。

Exosomes are emerging as a novel therapeutic candidate with potential to treat multiple indications. ReNeuron and UCL have a strong track record of collaborating in the area of exosome manufacture and we have delivered significant advancement for manufacturing exosomes via an Innovate UK grant and an existing EngD project. However, whilst we have explored options for recovery and purification of exosomes and made significant advancement in the upstream cell culture, there is still work needed to enhance purity of specific exosome subpopulations and to make meaningful measurements of the resulting product. Building on chromatographic methods already developed at UCL to remove process impurities, we will make further advancement towards a regulatory approved product, via enhanced polishing and new quantity and quality measurements. Specifically, we will aim to advance purification technology and measurement tools for high-purity recovery of exosome subpopulations from stem cells.