Patheon receives regulatory approval of new freeze-drying capabilities in Italy.
Expansion of commercial scale lyophilisation for sterile biopharmaceuticals production in Europe boosted by approval of Patheon’s facilities in Italy.
Patheon Inc. received final regulatory approval from the Italian Ministry of Health of its new lyophilisation capabilities in Monza and Ferentino, Italy.
Lyophilisation is a specialised manufacturing process during which products that are unstable in liquid form are freeze-dried in order to remove water and improve their stability.
As Patheon aims to be a leading European supplier of high value manufacturing services, Bob Tedford, Patheon’s CEO sees that approval of the new capabilities "marks a significant milestone."
Patheon’s Monza facility is approved to manufacture sterile lyophilised products and small-volume parenterals in both the newly constructed and existing sterile areas of the site, while renewing its authority to manufacture the full range of non-sterile liquid and solid dosage forms manufactured at the facility.
Completion and approval of the first phase of the company’s lyophilisation expansion program "provides Patheon with the added capacity needed to continue to grow this specialised and value-added service offering."
Patheon acquired the Ferentino facility in February 2002 and has expanded and upgraded the capabilities of the site, to manufacture sterile lyophilised products, as well as sterile large- and small-volume parenterals.
Demand is growing for lyophilisation services, from both biotechnology companies and other pharmaceutical companies who are developing more therapeutic proteins and other traditional small molecule-based products.
Keywords : Patheon Canada Italy Europe Contract manufacture Sterile production Lyophilisation Freeze drying Regulatory approval
