Kaneka Eurogentec, a custom service and FDA inspected Contract Development and Manufacturing Organization (CDMO) is proud to announce the certification of its new GMP Facility by the Belgian Federal Agency for Medicines and Health Products, FAMHP.
The new state-of-the-art facility allows the large-scale production of new generation of medicines.
The new facility audited and certified by Belgian Authorities is equipped with a 2200 L fermenter and is ready to start operating from this summer. It will complement the current biopharmaceuticals production capacity to further expand the offer from clinical studies (Phases I, II, III) to commercialization.
Large batch production of therapeutic molecules
Our multi-product facility is located on a single site and allows the development and the production of large scale of current and new generation of drugs and vaccines.
Beside the production of complex GMP recombinant proteins, conjugates and antibody fragments, Kaneka Eurogentec is considered as the world leader in Kg-scale biomanufacturing of GMP plasmid DNA for gene and cell therapies.
It will allow to respond to the need of pharma and biotech customers by producing in microorganisms large batches of plasmid DNA (corresponding to millions of doses) according to the GMP requirements, to be used as DNA vaccines or as starting material for mRNA and viral vectors.
Key Actor in Gene therapy
Accordingly, we are already in discussion with Pharma and large Biotech companies for the development and production of DNA based vaccines for testing trials for COVID-19 treatment.
More than 80 new employees
We already hired more than 80 full time scientific staff trained in the production of GMP therapeutic production and 50 are still upcoming for the whole company.