Thermo Fisher Scientific, a global leader in serving science, has recently received Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) for its manufacturing facility in Monza, Italy. This significant milestone enables the company to manufacture RNA-based products at this location, marking a crucial step in increasing accessibility to innovative therapies for patients with challenging medical conditions.

Dan Herring, General Manager of Advanced Therapies at Thermo Fisher Scientific, highlighted the importance of this development, stating, “RNA technology is being explored for a variety of modalities, including rare diseases and cancer which have limited treatment options.” He further emphasized that the AIFA GMP approval will assist the company’s customers in accelerating the development of new and life-saving therapeutics and vaccines, ultimately fulfilling the potential of RNA-based technology.

The Monza site is specialized in drug product manufacturing, including prefilled syringes, cartridges, and vials. The facility’s approval for RNA synthesis and lipid nanoparticle (LNP) formulation, combined with its sterile fill and finish capabilities, offers an enhanced end-to-end solution for customers involved in the development of RNA-based therapies and vaccines.

With over 30 years of experience in manufacturing sterile injectables, biologics, and advanced therapies, Thermo Fisher is well-equipped to support the development and global accessibility of these vital therapies.

Thermo Fisher Scientific, with annual revenues exceeding $40 billion, is committed to making the world healthier, cleaner, and safer through its mission to support customers in life sciences research, complex analytical challenges, laboratory productivity, patient health diagnostics, and the development and manufacture of transformative therapies. The company’s global team delivers an unmatched combination of innovative technologies and pharmaceutical services across leading brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

For more information, please visit Thermo Fisher Scientific’s website or contact their media representative Abbie Martin​​.

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