What's Happening?
AGS Therapeutics, a Paris-based company, is advancing its microalgae-derived extracellular vesicles (MEVs) as a next-generation drug delivery platform. The company has signed an agreement with INITS SMO, a GMP-qualified shared manufacturing organization in France, to transition its MEV manufacturing activities to full GMP compliance. This collaboration allows AGS to produce its first clinical-grade MEV batches while retaining full ownership and operational control of its technology and processes. The SMO model adopted by AGS provides a controlled environment to validate GMP processes and train teams, enabling progress toward clinical manufacturing without committing to a permanent site or long-term partner.
Why It's Important?
The development of MEVs as a drug delivery
platform represents a significant advancement in biopharmaceutical manufacturing. By utilizing microalgae-derived vesicles, AGS aims to create a more efficient and flexible drug delivery system that could benefit various pharmaceutical, vaccine, and cosmetic applications. The SMO model allows AGS to maintain strategic flexibility and reduce risks associated with early clinical manufacturing. This approach could lead to more rapid and cost-effective development of new therapies, potentially transforming the landscape of drug delivery and manufacturing in the biopharmaceutical industry.
What's Next?
AGS plans to manufacture GMP clinical batches for its lead programs targeting wet age-related macular degeneration and inflammatory bowel disease, with availability expected by the end of 2027. The company views this collaboration as a foundation for future GMP manufacturing activities, supporting partners in the pharmaceutical, vaccine, and cosmetic sectors. As AGS continues to develop its MEV platform, it may explore additional applications and partnerships to expand its reach in the biopharmaceutical market. The success of this initiative could pave the way for broader adoption of microalgae-derived drug delivery systems.
