The investments for the continuous improvement of the manufacturing processes and plants of Kedrion are going on at a fast pace.
After passing the AIFA inspection (AIFA is the Italian Drugs Agency) and proving to comply with international Good Manufacturing Practices (GMP), the process for the authorisation to operate with four new departments in the Bolognana plant (Lucca) has officially ended.
On one hand, the license to use the new department for filling and lyophilization of the coagulation inhibitor antithrombin (treatment of patients suffering from congenital and acquired antithrombin deficiency) as well as the new department for filling of standard intravenous immunoglobulin (which is also used as a replacement therapy in primary immunodeficiency syndromes, myeloma or chronic lymphocytic leukaemia) ends a process which had begun in 2001 and which involved the opening of the new Plasma Management department, the new Albumin manufacturing plant and the new area for aseptic filling and lyophilization of heat-treated coagulation factors.
On the other hand, the license to use the new raw materials warehouse and the new Quality Control Area (which includes chemical, biochemical, microbiological, PCR laboratories, coagulation laboratories and dedicated laboratories for viral markers and bacterial characterisation) ends the first stage of a further investment plan, which also includes an area for the viral validation laboratory which is well under way.
“The goal – explains Rodolfo Franceschini, Industrial Director of the company – is to extend the overall production capacity which enables Kedrion to satisfy the increasing needs of the Italian National Health System and to strengthen its position on those foreign markets where we are extending our presence both commercially and industrially".