Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Overview of Pathogen Inactivation of Blood Components versus Emerging Pathogens – Measures and Implementation Status ***

Minna Haapalahti (Abschlußjahr: 2010)

Language: English

Human blood is essential for life and has proved to be a valuable therapeutic agent for numerous medical disorders and treatment strategies. Blood components, plasma, red blood cells, white blood cells and platelets, as biological products however represent inherent risk to blood transfusion recipients. A number of infectious agents have been shown to be present in human blood. These pathogens include viruses, bacteria, parasites and prions. Current safety measures to reduce the risk of transfusion transmitted infections are based on careful donor selection, donor screening, optimized quality control and manufacturing aspects and on haemovigilance system.

New emerging pathogens for which no specific test exists require continuous surveillance through haemovigilance programs and risk assessment processes. So far the emerged risks have been approached with "an agent by agent" based measures by introducing new screening tests or setting up donor deferral criteria. Taking into account the wide range of emerging pathogens "an agent by agent" based approach seems not to be sustainable.

Pathogen inactivation measures have shown to provide a more reasonable way to handle these threats. The technological development around pathogen inactivation measures has evolved during the last years and technologies to cellular blood components have been developed. Pathogen-inactivated blood components have shown comparable efficacy, safety and quality to untreated components and all of these techniques have shown to inactivate and reduce a wide range of pathogens and consequently decreasing the risk of transfusion transmitted infections.

Current EU regulations do not require the introduction of pathogen inactivation measures as part of the preparation, quality and safety of blood components. The decision on the implementation of pathogen inactivation measures has been done nationally and many European countries have already introduced these measures as part of their blood supply practice.

The thesis reviews emerging pathogens as safety concern from blood supply perspective, currently available pathogen inactivation measures and their regulatory and implementation status in Europe.

Pages: 46, Annexes: 4, pages : 4