SARS-coronavirus (SARS-CoV) and the safety of a solvent/detergent (S/D) treated immunoglobulin preparation

SARS-coronavirus (SARS-CoV) is a newly emerged, highly pathogenic agent that caused over 8000 human infections with nearly 800 deaths between November 2002 and September 2003. While direct person-to-person transmission via respiratory droplets accounted for most cases, other modes have not been ruled out. SARS-CoV viraemia does not seem to reach high titres, however, it has to be excluded that virus transmission may occur via blood transfusion or application of therapeutic plasma products, e.g. fresh-frozen plasma or single components derived thereof. Manufacturing processes of all plasma derivatives are required to comprise dedicated virus inactivation/removal steps. Treatment with a mixture of solvent and detergent (SD) has successfully been applied to inactivate the most members of the transfusion-relevant viruses without affecting therapeutic properties of the products. The SD treatment irreversibly disrupts the lipid envelope of viruses such as HIV, HBV, HCV, HGV and CMV. In this study we evaluated the manufacturing process of an immunoglobulin preparation (OCTAGAM, manufactured by Octapharma Pharmazeutika Produktionsges.m.b.H., Vienna, Austria) for its capacity to inactivate the SARS-CoV. Our results demonstrate that SARS-CoV was completely inactivated below the limit of detection. This was found to occur within 1 min of SD treatment.