NR ATNV
AU Flan,B.; Aubin,J.T.; Kimmel,C.; Arrabal,S.; Chtourou,S.
TI Efficiency of TSE Elimination by Plasma Derived Products Manufacturing Processes
QU International Conference - Prion 2005: Between fundamentals and society's needs - 19.10.-21.10.2005, Congress Center Düsseldorf - Poster Session: Human prions, risk of blood products, and therapy HUMAN-19
PT Konferenz-Poster
AB
The emergence of the new variant of the Creutzfeldt-Jakob Disease (vCJD), mostly in the United Kingdom but also in France and other European countries, raised concerns about its possible transmission through exposure to blood and medicinal plasma derived products. Therefore, precautionary measures have been applied for the management of this risk, including the addition of specific transmissible spongiform encephalopathies (TSE) infectivity removal steps in the manufacturing processes of plasma derived medicinal products. The updated European Medicine Agency (EMEA) Position Statement concludes that, according to the latest scientific knowledge, the manufacturing processes for plasma derived medicinal products would reduce TSE infectivity if present in human plasma.
Here, we present data from studies investigating a wide range of manufacturing steps used by the Laboratoire Français du Fractionnement et des Biotechnologies (LFB, Les Ulis, France) in the manufacture of plasma derived products, for TSE removal. Besides data from conventional plasma fractionation steps such as ethanol fractionation, filtration and chromatography, we further focus on the contribution of 35 nm and 15 nm filtration in various applications as an additional safety step for plasma products. LFB data confirm the interest of nanofiltration for the further increase of the safety margin of plasma products with respect to the as yet unproven risk of vCJD transmission.
AD Benoit Flan, Jean-Thierry Aubin, Christine Kimmel, Samuel Arrabal, Laboratoire du Fractionnement et des Biotechnologies, Unité de Sécurisation Biologique, Les Ulis, France; Sami Chtourou, Laboratoire du Fractionnement et des Biotechnologies, Développement Pré-Clinique, Les Ulis, France
SP englisch
PO Deutschland