Thermo Fisher Scientific, the world leader in the service of science, has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) that allows the company to make RNA-based products at its Monza plant. The approval and associated certification support greater accessibility to new therapies for patients suffering from difficult-to-treat diseases, marking a significant milestone for the Thermo Fisher Scientific network and for Italy as a whole.

“RNA technology is being explored for a range of ways, including rare diseases and tumor, which have limited treatment options,” said Dan Herring, General Manager, Advanced Therapies, Pharmaceutical Services of Thermo Fisher Scientific. “Obtaining AIFA's GMP approval allows us to help our customers accelerate the development of new life-saving drugs and vaccines for patients, thus delivering on the promises of our RNA-based technology.”

The Monza office specializes in the production of drugs in pre-filled syringes, cartridges and vials. The approval of its GMP plant for RNA synthesis and lipid nanoparticle (LNP) formulation, and the presence of sterile filling and finishing functions at the same location supports a better complete solution for customers involved in the development of RNA-based therapies and vaccines.

With more than 30 years of experience in manufacturing sterile, biological and advanced therapy injectable drugs, Thermo Fisher has the skills and expertise to help customers accelerate development and increase access to therapies for patients around the world.