The new production department for sterile “Filling and Freeze-Drying of Heat-treated Coagulation Factors” in the Kedrion factory in Bolognana is now in operation. 7 million euros invested and a forecast increase of 50% in the production of Factor VIII and Factor IX which currently represent the 20% of turnover and the asset for the Contract Manufacturing, the organisation model with which the company works with Italian Regions.
The use of this factory is one step in Kedrion’s plan for reinforcing and developing its Italian factories in order to meet the commitments already undertaken as well as the increasing needs of the National Health System and also achieve the strategic target of expansion in foreign markets at both the commercial and industrial level.
Total value of the international market for Factor IX plasma concentrate (for treating Haemophilia B) is equivalent to 222 million US dollars, representing 485 million international units, and has a concentrate distribution of 34% in Europe (followed by South America with 19% and Asia and North America with 17%). With Factor VIII plasma concentrate (Haemophilia A), the figures are 935 million US dollars and 2,300 million units, and distribution again shows Europe in the top position with 41% (18% in South America, 15% in North America and 11% in Asia).
The newly installed equipment, new production lines, utilities and the corresponding quality documentation have all passed the AIFA (Italian Medicines Agency) inspection and the whole system was found to comply with international GMP’s (Good Manufacturing Practices) and meet the international requirements of both European and American (FDA) regulations.
“The Bolognana factory” – explained Kedrion’s Industrial Director, Rodolfo Franceschini – “is an industrial establishment of excellence in the plasma-derived products sector in the international context. The introduction of new equipment totally dedicated to Heat-treated Factors does not change the manufacturing process but allows a better rationalization in the production of these products. The new structure and the consequent increased product availability will, on the one hand, mean access to foreign markets and on the other, allow us to supply a greater quantity to the National Health System through the Contract Manufacturing model, which will mean a significant reduction in public spending”.
Since 2001, revamping operations have been performed in the Bolognana factory on the Plasma Fractionation Department, which is the fulcrum of plasma-derivative production. New production units have been created such as an ethanol recovery plant, a Plasma Management Department equipped with two cold rooms for plasma storage at -35°C with a capacity of approx. 500,000 litres of plasma, a Department for Bulk Production of Factor VIII and an Albumin Production Department.
Further developments are planned for the period 2007-2010, namely, new departments for Filling and Freeze-Drying of Antithrombin III, Filling of Ig Vena, AT III Bulk Production, Factor IX Bulk Production, a new laboratory building, a new plant of Alpha-1-Antitripsyn Production, as well as general expansion of auxiliary structures and new partnerships which will lead to a fractionation capacity of approx. 1.3 million litres of plasma per year.
