Patheon has opened a new Pharmaceutical Development Services (PDS) manufacturing site for investigational medical products within its existing manufacturing facility in Ferentino, Italy.

The new facility will manufacture sterile products including aseptically filled, terminally sterilized liquids and lyophilization. It also includes development and quality control labs. Three lyophilization units will be available, with two dedicated to development activities for non-human use and one dedicated to the manufacture of clinical trial materials.

The area is designed to accommodate future expansion and is set up specifically for the scale-up of products for clinical use following the completion of development activities on site, and will support mechanisms for the manufacture of biopharmaceutical products. Capabilities will include the manufacture of highly potent drugs, poorly soluble, oxygen and light sensitive compounds, and highly hygroscopic lyo-products. The space is also equipped with a dedicated water and HVAC system.

The expansion doubles PDS manufacturing capabilities for clinical batches and analytical lab capabilities. The new area will be completed for use in November 2009 and will employ an additional 10 process specialists and development scientists.

Patheon’s chief executive officer, Wes Wheeler, stated, “Our new PDS facility will be of strategic importance in order to feed the pipeline of Patheon’s two commercial sites located in Italy, offering clients a one-stop shop, from early development all the way through to commercial manufacturing.”