Kaneka Eurogentec, a custom service and FDA inspected Contract Development and Manufacturing Organization (CDMO) received GMP accreditation by the Belgian ministry of health for the GMP manufacturing of messenger RNA (mRNA).
A new GMP facility for active pharmaceutical ingredient production
The new facility audited and accredited by Belgian Authorities will allow the production and the purification of up to 10 g scale ( up to 1 Million doses of vaccine) of RNA for use in human clinical trials and commercial supply, with potential for expansion.
Strengthening Eurogentec’s position as a leader in gene therapy
Dr. Lieven Janssens, Kaneka Eurogentec’s President and CEO, said, “Manufacturing GMP mRNA complements perfectly our ongoing GMP DNA manufacturing activities providing a one-stop-shop offering Plasmid DNA, linearization and mRNA production. It’s definitely the ambition of Kaneka Eurogentec to become the world leading CDMO for mRNA, as we are already for the production of plasmid DNA.”
Two mRNA contracts already signed
The expertise of the company for more than 25 years as CDMO for the manufacturing of GMP Biopharmaceuticals is recognized worldwide. Two customers have already signed for three mRNA sequences including for early phase COVID-19 clinical trials.