EXO Biologics and its subsidiary, ExoXpert Achieves GMP Certification for Exosome Manufacturing Facility in Europe

• EXO Biologics and its subsidiary, ExoXpert, announce that ExoXpert is the first European exosome CDMO to receive Good Manufacturing Practice (GMP) certification for its facility in Liège, Belgium.

• The company has also successfully loaded mRNA and DNA payloads into GMP-grade exosomes, marking a key step in the development of non-viral gene therapies.

EXO Biologics and its CDMO subsidiary, ExoXpert, innovators in exosome-based therapeutics and drug delivery solutions, has achieved a significant milestone with its subsidiary ExoXpert becoming the first European CDMO to receive Good Manufacturing Practice (GMP) certification. The certification, awarded by the Belgian federal agency for medicines and health products, pertains to ExoXpert’s exosome manufacturing plant in Liège, Belgium. This development allows the company to provide GMP-grade exosome production capabilities to clients in both the US and EU markets.

The certification enables EXO Biologics to internally produce its lead asset, EXOB-001, a therapeutic currently in clinical phase I trials. The GMP-compliant facility also supports regulatory submissions and clinical trials for other exosome-based products, particularly in gene and cell therapy applications.

In addition to the certification, EXO Biologics has made a significant breakthrough by successfully loading mRNA and DNA payloads into GMP-grade exosomes. This achievement further accelerates the potential for non-viral gene therapies, including cancer immunotherapies and vaccines. The successful loading of these larger molecules into exosomes opens the door to safer, more effective gene delivery systems, offering a promising alternative to traditional viral-based technologies.

Hugues Wallemacq, CEO of EXO Biologics, stated, “We are now working on optimising the loading technology to further reduce manufacturing costs and strengthen the attractiveness of exosome therapeutics.” The company is focused on enhancing the scalability and efficiency of its exosome manufacturing platform to support the growing demand for these therapies.