Small batch GMP fill & finish for exosome-based therapies

ExoXpert is a CDMO specializing in the GMP manufacturing of exosomes. With a focus on accelerating the development of exosome-based therapies, ExoXpert partners with pharmaceutical companies to leverage its deep expertise, helping them expedite clinical trials and bring innovative exosome-driven pharmaceutical products to market more swiftly.

Exosomes

Exosomes are extracellular vesicles naturally released by nearly all cell types in the body, especially stem cells. They retain many of the biological properties of the cells from which they originate, making them invaluable for a range of therapeutics applications. Due to their nature, exosomes must be manufactured under stringent sterile conditions and stored at cryogenic temperatures to preserve their integrity and effectiveness.

Exosomes represent an emerging therapeutic frontier, offering innovative solutions for new therapeutics, drug delivery vehicles, and regenerative medicine. As this field is still in its infancy, current demand focuses on small, highly specialized batches tailored for research and early-phase clinical trials. However, the potential for broader applications in areas like oncology, neurology, and immunotherapy suggests that scaling up production may become essential as therapies progress toward commercial viability. Therefore, flexible manufacturing solutions that can accommodate both small-scale and large-scale production are critical to meeting current needs while preparing for future growth.

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The ExoXpert project

ExoXpert is a GMP compliant Belgian CDMO specializing in exosomes. As a subsidiary of EXO Biologics, ExoXpert offers a dedicated facility for the GMP manufacturing of exosomes for clinical application. With a track record in supporting EU clinical trials, ExoXpert is committed to helping companies develop affordable and accessible exosome therapies for patients. Powered by the ExoPulse platform, ExoXpert ensures the GMP-compliant production, purification and characterization of exosomes, meeting the highest standards of quality and consistency for therapeutic development.

For their fill & finish process, ExoXpert required a safe solution tailored to small batch production and fully compliant with GMP Annex 1. The AT-Closed Vial® and the Crystal M1 Filling Station were the ideal fit, providing the precision, safely, and efficiency to meet their specific needs.

The AT-Closed Vial® is closed and sterilized prior to filling, minimizing contamination risks by eliminating open steps during the filling process. The vials’ materials are fully compatible with cryopreservation, ensuring the safe storage of sensitive products, such as exosomes.