Thermo Fisher Gets GMP Approval for RNA Products in Italy

18 Sep, 2024

Thermo Fisher Gets GMP Approval for RNA Products in Italy

Thermo Fisher Scientific has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) for its RNA-based product manufacturing facility in Monza, Italy. This significant certification allows Thermo Fisher to enhance its capabilities in producing RNA-based therapies, contributing to the development of innovative treatments for challenging conditions.

The GMP approval supports the production of RNA-based products, including therapeutics and vaccines, addressing diseases with limited treatment options such as rare diseases and cancer. Dan Herring, General Manager of Advanced Therapies at Thermo Fisher Scientific, highlighted the importance of this achievement in accelerating the development of life-saving RNA-based technologies.

The Monza facility is equipped to handle drug product manufacturing in prefilled syringes, cartridges, and vials. The facility’s capabilities extend to RNA synthesis and lipid nanoparticle (LNP) formulation, offering a comprehensive end-to-end solution for RNA-based therapies and vaccines. With over 30 years of experience in manufacturing sterile injectables, biologics, and advanced therapies, Thermo Fisher Scientific is well-positioned to support the global development and accessibility of novel treatments for patients.