Day 2 - Exosomes EuropeThursday, 5 November 2026

• Scaling from benchtop to commercial-volume automated bioreactors
• Molecular impact of transitioning from 2D to 3D culture
• Developing real-time monitoring strategies for vesicle concentration during upstream processing
• Using chemically defined media to reduce variability between lots

Leveraging its proprietary platform of EV production by turbulence, EVerZom is advancing its lead therapeutic candidate, EVerGel, a thermoresponsive hydrogel loaded with MSC-derived exosomes designed for localized regenerative therapy. Upon injection, the formulation undergoes a sol–gel transition at physiological temperature, enabling sustained delivery of bioactive EV-enriched secretome directly at the lesion site. Preclinical studies in multiple animal models have demonstrated enhanced tissue repair, accelerated wound healing, and immunomodulatory effects. EVerGel™ is currently progressing toward clinical evaluation for the treatment of complex gastrointestinal lesions, including perianal fistulas associated with Crohn’s disease.

Exogenus Therapeutics is developing an EV-enriched secretome product derived from umbilical cord blood cells, EXO-101, for Regenerative Medicine therapeutic applications. Here, we will share insights about the development of EXO-101 towards the clinics, including the strategy to:

• Achieve scalable GMP-production of an EV-enriched secretome product derived from a non-conventional raw material
• Conciliate input from different regulatory agencies to achieve robust product regulatory compliance
• Establish a clinical development plan for EV-based modalities until Phase 2 efficacy demonstration, for indications with long-term readouts

• Predicting the "mRNA moment" for exosome-based vaccine and therapy delivery
• The evolution of cell-free therapeutics as a solution to scalability hurdles
• Long-term vision for standardized, high-volume exosome manufacturing hubs
• Final assessment of manufacturing breakthroughs needed in the next 5-8 years.