Thermo Fisher Scientific, the world leader in serving science, has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) allowing the company to manufacture RNA-based products at its Monza, Italy site. The approval and associated certification support increased accessibility to novel therapies for patients with difficult to treat conditions, marking a significant achievement within the Thermo Fisher Scientific network and for Italy as a whole.

“Obtaining AIFA GMP approval enables us to help our customers accelerate the development of new and life-saving therapeutics and vaccines for patients – and ultimately deliver on the promise of RNA-based technology.”

“RNA technology is being explored for a variety of modalities, including rare diseases and cancer which have limited treatment options,” said Dan Herring, General Manager, Advanced Therapies, Pharma Services at Thermo Fisher Scientific. “Obtaining AIFA GMP approval enables us to help our customers accelerate the development of new and life-saving therapeutics and vaccines for patients – and ultimately deliver on the promise of RNA-based technology.”

The Monza site specializes in drug product manufacturing in prefilled syringes, cartridges and vials. The approval of its GMP facility for RNA synthesis and lipid nanoparticle (LNP) formulation, plus its co-location with sterile fill and finish, supports an enhanced end-to-end solution for customers engaged in the development of RNA-based therapies and vaccines.

With more than 30 years of experience manufacturing sterile injectables, biologics, and advanced therapies, Thermo Fisher has the capabilities and expertise required to help customers accelerate development and increase access to therapies for patients globally.