Plasma system, exporting the Italian “Contract Manufacturing” model to Chile

“Teamwork to improve plasma quality in Chile” is based on an agreement made in November 2005 by the Ministry of Health in Chile and SIMTI (Italian Transfusion Medicine and Immunohaematology Company), which marked the operational meeting between the Chilean delegation specially flown in to Italy and the CNR (National Research Council), SIMTI, Tuscany’s CRCC (Regional Centre for Coordination and Clearing), the transfusion centre in the Careggi Hospital in Florence, and Kedrion Biopharmaceuticals SpA’s industrial plants in Tuscany. The objective: to introduce processes that will result in continuous improvement in Chile’s Plasma System, from collection to fractionation, and from quantity and distribution to research into current levels of quality and production of drugs in Chile.

“Our mission in Italy can be regarded as a success,” declared the delegates from the Chilean Ministry of Health, Dr Homero Vasquez, head of the Quality of Health Department and Dr Alfredo Bravo Civit, in charge of the Cooperation and International Affairs Office (OCAI). “SIMTI’s support in improving the quality of plasma in Chile has been consolidated and will mean the realisation of different kinds of technical support which are very much needed, since a significant part of Chilean plasma has been removed for a number of reasons, and only a small part is sent for rudimentary industrial fractionation in order to produce haemoderivates, mainly albumin”.

From this has come agreement for a combined project that will be set up in “speeded up” stages in the second half of this year. There is also an important appointment – the inauguration of a new collection centre in Region IV and V in Chile on the occasion of the celebrations for World Blood Donor Day on 14 June.

In addition, there is a reference model – the “processing account” adopted in Italy. Set up in 1984 and adopted by institutions in 1990, the “processing account” is based on strategic partnership between the Health System, Industry and Blood Donor Associations. In Italy, in the space of 20 years, this has meant an eleven-fold increase in the availability of pharmaceutical plasma derivates from national plasma and an increase in fractionation from the 50,000 litres recorded in 1986 to 550,000 in 2005.

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