VIRAL SECURITY OF INTRAVENOUS G-IMMUNOGLOBULIN PREPARATIONS FOR THERAPEUTIC USE

Even though IV IgG concentrates are considered to be among the safest products derived from human plasma, some preparations have been associated with the sporadic transmission of NANB hepatitis and, specifically of hepatitis C. The risk of transmission may have decreased markedly for several IgG preparations since the availability of an immunological test to detect the antibodies against HCV in the starting plasma, but it has not been fully eradicated. Thus, in addition to established viral inactivation treatments, such as acid pH incubation, new methods have been (or are being) implemented to further reduce the risk of HCV infection through IV IgG concentrates. Among these methods are the solvent-detergent treatment already shown to be highly effective for the inactivation of HCV and other enveloped viruses in clotting factor concentrates, and nanofiltration for the specific removal of viruses on the basis of their size. Also, chromatographic methods have helped to improve the overall safety of the product not only by removing viruses but also by improving purity and thus favoring a better in vivo tolerance. This paper reviews the reported cases of HCV transmission and the viral validation data for various IV IgG processing steps and current specific viral inactivation methods. An overview of the present safety status of IV IgG concentrates is presented as well as the recent introduction of new promising techniques for the overall improvement of the safety of this plasma derivative.