OVERVIEW

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

PDS Ferentino is based at Patheon’s Ferentino Operations. The development facility is specially designed for the development of sterile lyophilized products, including biopharmaceuticals and small chemical entities.

PDS Ferentino offers expertise in formulation, cycle optimization, and CTM manufacture of lyophilized products in pre-clinical stages through to scale-up and registration batches. The PDS team of scientists at Ferentino is dedicated entirely to the development of lyophilized products.

PDS Ferentino operates three dedicated development lyophilization units ranging in size from 0.2 m² to 0.8 m². One of our development lyophilization units includes a “Sample Thief” which enables our scientists to optimize the drying cycle by accurately monitoring moisture levels throughout the cycle. Our lyophilization development units have been modified to match the performance of larger scale production units, simplifying the scale-up process. With an aseptic fill line dedicated exclusively to customer development projects, and a 7 m² cGMP lyophilizer for scale-up and registration batches, PDS Ferentino can optimize the development process for your lyophilized product.

All development activities are supported with comprehensive analytical and bio-analytical support. PDS Ferentino also employs a Qualified Person (QP) to support the release of finished products and clinical materials within Europe.

Lyophilization development at PDS Ferentino is fully integrated with commercial scale capabilities at Ferentino and Monza Operations, Italy. Please click on the Commercial icon above to learn more about commercial capabilities at Ferentino Operations, and on Monza Operations for commercial capabilities at the site.