Thermo Fisher Scientific 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.
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.
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