Production Consortium Europe – U.S.
The production process of plasma proteins contains three steps. The first step is the plasma extraction, usually by plasmapheresis. The plasma is separated from the donor blood, and the corpuscular components (e.g. erythrocytes) are directly retransfused into the donor. The second step is the fractionation, where the plasma is separated in its individual protein components (fractions). The third step is the purification.
Biotest produces plasma proteins in Europe and in the U.S. In Europe, with the facilities in Dreieich/Germany and by means of agreements with co-operation partners, we have at our disposal a yearly capacity to process 1 million litres of blood plasma. A facility in Boca Raton, at the site of BPC, is designed for a production quantity of 400,000 litres per year.
From 2012, we will be able to produce at both sites together about 5.5 tons of immunoglobulins per year – 4 tons in Europe and 1.5 tons in the U.S.
We plan to obtain approval for both production facilities by the European as well as by the American regulatory agencies. This will allow us to establish a transcontinental production consortium. It will thus be possible to further process in Germany primary and semifinished products that have been produced in the U.S.
The plasma we process is either extracted in our own donor centres or we obtain it from qualified partners. Biotest operates donor centres in Europe and in the U.S. European authorities have certified the American centres. Biotest can thus use plasma obtained in these centres for the production in Dreieich/Germany.