We are pleased to announce that Dr. Andreia M. Silva (Exogenus Therapeutics, S.A., Portugal) will join Targeting Extracellular Vesicles 2026 as a speaker.

Advancing Extracellular Vesicles (EVs)-based drugs towards clinical applications has posed significant manufacturing challenges, particularly in the context of a regulatory framework that remains largely undefined for this emerging drug modality. With more EV drugs reaching the final stage of pre-clinical development, developers worldwide have been adopting different strategies for EV drugs manufacturing and control, where common practices and frameworks are starting to emerge, and which can be implemented early in product development to accelerate clinical translation.     

This presentation will draw on Exogenus’ experience gained throughout the development of its lead asset, to discuss emerging consensus strategies for implementing EV manufacturing workflows compatible with GMP requirements. It will also address process and product quality control approaches, as well as the definition of Critical Quality Attributes (CQAs) that support the release of EV batches for clinical use.