Turning Microalgae-Derived Extracellular Vesicles Into a Next-Generation Drug Delivery Platform

Paris-based AGS Therapeutics (AGS), which is focused on turning microalgae-derived extracellular vesicles (MEVs) into a next-generation drug delivery platform, signed an agreement with INITS SMO, a GMP-qualified shared manufacturing organization (SMO) also in France, to support the transition of its MEV manufacturing activities to full GMP compliance and enable the production of its first clinical-grade MEV batches.

AGS will operate its proprietary MEV manufacturing, loading, and analytical processes within INITS’s infrastructure. AGS retains full ownership and operational control of its technology, processes, equipment, intellectual property, and teams.

The collaboration is structured as an SMO model, distinct from a contract development and manufacturing arrangement. No technology transfer is performed, and no third party takes operational ownership of AGS’s processes.

This agreement represents a deliberate and transitional operational step, according to AGS officials. It enables AGS to reach GMP maturity and key manufacturing milestones in parallel with the continued preparation of its own independent, modular GMP demonstration manufacturing unit, they explained, adding that this approach enables progress toward clinical manufacturing without committing at this stage to a permanent site, long-term manufacturing partner, or fixed industrial footprint.

By combining speed of execution with capital discipline, the SMO framework significantly reduces risk in early clinical manufacturing while preserving strategic flexibility, noted Marie-Hélène Leopold, AGS’s chief corporate development officer. It provides AGS with a controlled, inspection-ready environment to validate GMP processes, train teams, and consolidate industrial know-how, while maintaining full optionality for future scale-up, internalization, or alternative manufacturing configurations, pointed out a company spokesperson.

Through this agreement, AGS plans to manufacture GMP clinical batches for its two lead internal programs: AGS-1010 for wet age-related macular degeneration and AGS-2010 for inflammatory bowel disease, with GMP batch availability targeted for the end of 2027. In addition, AGS views the collaboration as a foundation for future GMP manufacturing activities supporting pharmaceutical, vaccine, and cosmetic partners developing MEV-based products.

“The SMO model gives us the right balance between operational rigor, capital efficiency, and independence,” said Leopold.

“Our focus is to ensure that AGS’s manufacturing processes are robust, reproducible, and inspection-ready from the outset. This framework allows us to consolidate GMP capabilities internally and prepare a seamless transition toward our own dedicated manufacturing unit when the time is right,” stated Lila Drittanti, co-founder and CSO/COO, AGS.