Pharma Focus Europe

Thermo Fisher Scientific's Monza, Italy Manufacturing Facility Secures GMP Approval from the Italian Medicines Agency (AIFA) for RNA-Based Products

Friday, January 19, 2024

Thermo Fisher Scientific, a prominent player in advancing scientific solutions globally, has recently obtained Good Manufacturing Practice (GMP) approval from the Italian Medicines Agency (AIFA) for its Monza facility in Italy. This approval authorizes the manufacturing of RNA-based products at the site, representing a significant milestone for both the company and Italy.

The GMP approval and associated certification signify a crucial step towards enhancing access to innovative therapies, particularly for patients facing challenging medical conditions. This achievement underscores Thermo Fisher Scientific's dedication to advancing scientific research and contributing to the healthcare landscape.

RNA technology is rapidly evolving, exploring applications across various modalities such as rare diseases and cancer, where traditional treatment options are often limited. According to Dan Herring, General Manager of Advanced Therapies, Pharma Services at Thermo Fisher Scientific, securing AIFA GMP approval positions the company to play a pivotal role in expediting the development of novel therapeutics and vaccines utilizing RNA-based technology.

The Monza site, specializing in drug product manufacturing in prefilled syringes, cartridges, and vials, has now been approved for RNA synthesis and lipid nanoparticle (LNP) formulation. Its strategic co-location with sterile fill and finish operations enhances overall end-to-end capabilities, providing customers engaged in RNA-based therapy and vaccine development with a comprehensive solution.

With over three decades of experience in manufacturing sterile injectables, biologics, and advanced therapies, Thermo Fisher Scientific is well-equipped to assist customers in accelerating development processes and increasing global access to life-changing therapies. This achievement reinforces the company's position as a trusted partner in the advancement of medical science.



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