Signal Over 200 exosome clinical trials since 2022, with yields reported up to fifty-fold higher

Summary

The report explains why exosome drug delivery has become more viable in recent years. In the early 2020s, automated systems, three-dimensional bioreactors and new purification methods arrived at nearly the same time. Together they raised production yields by up to fifty-fold and made clinical-scale manufacturing possible for the first time. Regulators including the FDA and the European Medicines Agency then classified exosome therapies as biological medicinal products, giving developers a category to work in while approval rules are still being drafted. Since 2022, more than 200 clinical trials have started across cancer, neurological disease and the long-term effects of COVID-19. The outlook expects diagnostics to be adopted first, since reading exosomes is easier than engineering them for therapy.