Poster Presenter

Influenza A Virus H1N1 And The Safety Of Plasma Products
In Seop Kim, Eun Kyo Jeong AND Hark Mo Sung
South Korea

Pandemic H1N1 2009 influenza virus has been identified as the cause of a widespread outbreak of febrile respiratory infection. Although the severity of this illness has ranged from mild to severe, little has been reported about how this outbreak has affected the safety of plasma derivatives as well as blood for transfusion. To evaluate the safety of plasma derivatives, dedicated virus clearance processes used during the production of plasma derivatives were investigated for their effectiveness in inactivating and/or removing this virus of recent concern. In this study, influenza A virus H1N1 strain A/NWS/33 (H1N1) was chosen as the model of pandemic H1N1 2009 influenza virus. H1N1 was completely inactivated by fraction IV fractionation and pasteurization for albumin. H1N1 was also effectively partitioned by fraction III fractionation and completely inactivated by pasteurization and low pH incubation for immunoglobulins. Solvent/detergent treatment was an effective process for inactivating H1N1. It was completely inactivated to below detectable level within 1 min of treatment using 0.3% tri (n-butyl) phosphate and 1.0% Triton X-100 for antihemophilic factor VIIII, and 0.3% tri (n-butyl) phosphate and 1.0% Tween 80 for antihemophilic factor IX. H1N1 was completely removed during virus filtration process using Viresolve NFP filter and also completely inactivated by pasteurization for anti-thrombin III. These results indicate that all the commonly used virus clearance processes investigated for the production of albumin, immunoglobulins, factor VIII, factor IX, and anti-thrombin III have sufficient H1N1 reducing capacity to achieve a high margin of safety.

[This research was financially supported by the Ministry of Knowledge Economy (MKE) and Korea Industrial Technology Foundation (KOTEF) through the Human Resource Training Project for Strategic Technology]