EXO Biologics (and its CDMO subsidiary, ExoXpert) has announced it has received Good Manufacturing Practice (GMP) certification for its manufacturing plant in Liège, Belgium. 

In addition, the company says it has managed to achieve the loading of GMP-grade exosomes with mRNA and DNA payloads, describing it as “a major milestone for the development of exosome-based therapies”. 

The GMP certification was awarded by the Belgian federal agency for medicines and health products. 

This will enable EXO Biologics to internalise the production of EXOB-001, its lead asset currently in clinical Phase I and the first global EMA-approved MSC-based exosome therapeutic clinical trial. 

Currently, the greatest demand is for the use of exosomes as a safe and non-viral drug delivery system for cell & gene therapy applications. 

The company has also successfully completed loading a number of chemical molecules and nucleic acids into exosomes from various cell sources. 

Small molecules and short nucleic acids (siRNA and miRNA) have already been validated in an end-to-end GMP-like setting, but so far EXO are the first to load larger molecules, such as mRNA and DNA, into GMP-grade exosomes. Preliminary data from the company’s trials show a retention rate up to 80% of the loaded DNA cargo upon exosome loading.  

Exosomes, as naturally occurring extracellular vesicles, are increasingly recognised for their ability to transport biologically active cargo, such as mRNA and DNA, with reduced immunogenicity and enhanced cellular uptake. 

“We have now achieved two critical strategic milestones by the end of 2024, which extends our continued progress in developing scalable, GMP-compliant solutions for exosome as therapeutic and drug delivery system. This extends our market leading position in the development of exosome-based technologies, unlocking new possibilities for drug delivery, gene therapy, and immunotherapy,” said Hugues Wallemacq, CEO of EXO Biologics.

Diana Spencer, Senior Digital Content Editor, DDW