Thermo Fisher’s Monza Mfg. Facility Receives GMP Approval

Thermo Fisher Scientific has received GMP approval from the Italian Medicines Agency (AIFA) allowing the company to manufacture RNA-based products at its Monza, Italy site. 
 
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 services for customers engaged in the development of RNA-based therapies and vaccines.
 
“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.”