A little more careful than others... How AGES ensures safe hemophilia medicines
World Hemophilia Day 2018
Hemophilia is a congenital, lifelong increased bleeding tendency in which a deficiency or complete absence of certain blood components (clotting factors) leads to a disturbance of normal hemostasis. Approximately 850, predominantly male, individuals are affected in Austria. A distinction is made between hemophilia A and hemophilia B. Inheritance occurs via the X chromosome and only has an effect if there is no healthy X chromosome as the second sex chromosome. Since girls have 2 X chromosomes and boys have one X and one Y chromosome as sex chromosomes, boys are usually affected by the disease.
Blood plasma and the role of AGES Medical Market Surveillance
70% of all hemophilia patients are regularly dependent on the supply of a coagulation factor preparation; a single patient alone requires 1,200 l of plasma donations. Every year in Austria, more than four million liters of plasma are processed into various drugs or coagulation preparations. Each individual batch produced using human blood or plasma must be checked and approved by the manufacturer on the one hand, and by a government control laboratory on the other.
AGES laboratory leads the way in Europe
In Austria, this is carried out by the OMCL (Official Medicines Control Laboratory) of AGES Medizinmarktaufsicht. The OMCL tests the plasma pool for HIV antibodies and hepatitis B and hepatitis C antigens, among other things, using viral markers. Furthermore, the testing of coagulation concentrates for fibrin adhesives is carried out, which are used e.g. during emergency operations or surgical procedures with high blood loss (liver operations, transplantations). Recombinant preparations produced with the aid of genetically modified microorganisms or in cell cultures also fall under the controlling analyses of AGES.The strict legal and analytical quality criteria are having an effect: since the 1980s, there has not been a single case of infection in connection with plasma products.
Vienna: World Capital of Plasma Fractionation - OMCL Leading in Europe
With 65 liters of blood plasma donated per 1,000 inhabitants, Austria is the country with the second highest donation rate in the world behind the USA. 18 of the 84 European plasma donation centers are located in Austria. With more than 3,000 examinations per year, the Austrian control laboratory holds a top position in the analysis and evaluation of plasma testing.If a product receives approval for the market, it must continue to be continuously monitored for its effectiveness or for side effects or interactions with other preparations that occur in practical use. The experts of AGES Medical Market Surveillance therefore also examine biomedical medicinal products (medicinal products made from blood components such as plasma, etc., medicinal products made from sera such as vaccines, etc.) with regard to safety and efficacy.The core task of a drug control laboratory is, on the one hand, to control the quality of medicinal products on the legal market. This involves laboratory analysis of samples to determine whether the properties (identity, purity and active ingredient content) meet the requirements of the marketing authorization and the monographs of the European Pharmacopoeia.Another very important task, on the other hand, is the analysis and evaluation of samples suspected of being illegal drugs. The laboratories cooperate in international networks and play an important role in the quality assurance of medicinal products as well as in the monitoring of the global pharmaceutical market.
Inquiries (technical)Dr. Christoph Baumgärtel, Tel.: 050555/36004E-Mail:christoph.baumgaertel@ages.atRückfragen (for media)Communications Management AGES/BASGE-Mail: presse-basg@basg.gv.at
