OVERVIEW

• Facility area:
  • 144,000 ft² (13,400 m²)
• Commercial manufacturing area:
  • 134,600 ft² (12,500 m²)
• Regulatory approval:
  • DVMF Ministero della Salute (Italy)
  • U.S. FDA
• Pharmaceutical Development Services (PDS Ferentino Italy)
  • Pharmaceutical Development Services area: 9,400 ft²  (870 m²)

Patheon’s Ferentino Operations, Italy, which is entirely dedicated to sterile manufacturing and development offers complete lyophilization services for biopharmaceuticals and small molecules. The facility houses four state-of-the-art cGMP lyophilization units ranging in shelf space from 75 ft² (7 m²) to 452 ft² (42 m²), with a total lyophilization production capacity of 990 ft² (92 m²). Lyophilization services are fully supported with comprehensive in-house analytical and bio-analytical capabilities to ensure the highest product quality.

Ferentino Operations’ recently designed and constructed lyophilization areas meet the highest regulatory standards and include both European and U.S. FDA-approved manufacturing capabilities for lyophilized products.

Patheon’s Monza Operations also offers significant commercial lyophilization capacity. Click here to learn more about Monza Operations.

The facility is also designed for the aseptic filling of small volume parenterals (SVP) and offers a dedicated sterile suite for large volume parenterals (LVP) filled in glass bottles. Ferentino Operations also offers disposable manufacturing technologies.

Patheon’s European facilities all employ a Qualified Person (QP) to ensure prompt release of products within the European market.

Patheon’s lyophilization Development Center of Excellence is located at Ferentino Operations. Please click on the PDS Ferentino Italy icon above to learn more about integrated lyophilization development services at PDS Ferentino.