Patheon offers fully integrated lyophilized product manufacturing services which can accommodate a wide range of molecules types:
- Small chemical molecules
- Proteins and peptides
- Monoclonal antibodies (MAb)
- High-potency actives
Patheon is positioned at the forefront of lyophilization technology with three state-of-the-art lyophilization facilities. Patheon's lyophilization facilities are located at Ferentino and Monza, Italy as well as a new lyophilized cephalosporin facility at our Swindon, UK site opened in 2007.
Our modern facilities offer lyophilization services for bulk units and can efficiently fill your valuable molecule to your specifications in a variety of finished packaging formats including ampoules and vials.
In Italy, our five newly designed manufacturing suites house 10 modern lyophilization units ranging in size from 7m2 to 42m2, with a combined capacity of 3,150 ft2 (292m2). This extensive amount of cGMP capacity allows our lyophilization facilities to accommodate the high-volume commercial scale lyophilization needs of our customers.
Patheon's Italian sterile manufacturing facilities meet the high quality standards of Europe and abroad. In addition to holding European regulatory approval, the Monza and Ferentino facilities offer U.S. FDA-approved lyophilization capacity.
Our newly constructed lyophilization facility located in Swindon, UK exclusively manufactures sterile lyophilized cephalosporin products at a commercial scale. With five sophisticated sterile suites the facility is capable of producing high-volumes of lyophilized cephalosporin products to customer specifications.
Our manufacturing areas were constructed using specialized building materials and incorporate robust environmental control systems. All of the units and formulation tanks have "clean in place" (CIP) and "steam in place" (SIP) functions to ensure the consistent sterilization of the chambers and the processing equipment.
Patheon backs up our world class lyophilization manufacturing capabilities with full service Quality Control (QC) support with sterility testing performed using modern isolators. All of Patheon's European sites employ a highly trained Qualified Person (QP) to support the release of finished products.