Monza, Italy

Specilized capabilities

• mRNA drug substance manufacturing, analytical, and development

• Lipid nanoparticles (LNP) formulation manufacturing, analytical, and development

• Prefilled syringes

• Sterile lyophilized products

• Sterile liquids (SVP)

• Cartridges

• Biopharmaceuticals

• Controlled drugs

• Secondary packaging (vials)

• Commercial fill-finish lines
• Visual Inspection Capabilites
  • 100% automatic visual inspection
  • Semiautomatic visual inspecion
  • Manual visual inspection

Recently, Monza established a new state-of-the-art center of excellence for sterile injectables development. All manufacturing services are fully supported by our comprehensive in-house analytical and bioanalytical capabilities. Additionally, the facility employs Qualified Persons (QPs) to ensure the prompt release of bulk products within the European market.

Monza offers compliance with controlled drug regulations in Europe and the US, as well as disposable manufacturing technologies and fully integrated secondary packaging services. It has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, and Turkey.

The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.

Recent investments in sterile development capabilities

In 2017, Thermo Fisher Scientific made a $25 million investment to establish sterile development capabilities in Monza. This was part of a $150 million total investment in sterile capabilities since 2015, including investments in Greenville, NC and Ferentino, Italy.

Learn more about the specific equipment and CDMO capabilities available in Monza by downloading our site fact sheet.