Effective inactivation of a wide range of viruses by pasteurization

Gröner, Albrecht; Broumis, Connie; Fang, Randel; Nowak, Thomas; Popp, Birgit; Schäfer, Wolfram; Roth, Nathan J.

Inactivation of HEV, a reemerging virus of concern, is currently under evaluation in a wide variety of stabilized product intermediates (to be published separately). Based on data presented or published, 28 Currently, many complementary safety measures are in place to prevent the transmission of blood-borne viruses by the administration of commercial plasmaderived products. These measures include licensed blood and plasma collection centers with appropriate epidemiology regarding HIV, HCV, and HBV in plasma donors, 32 mandatory and voluntary testing of all donations for these viruses as well as for HAV and high titers of B19V, 33 releasing plasma pools for fractionation for further manufacturing only when nonreactive for virus markers (and not exceeding 10 4 B19V DNA IU/mL), and the implementation of effective virus reduction steps in the manufacturing process of plasma-derived products. 15 Based on these measures the risk of transmitting blood-borne viruses via the administration of plasma-derived products is very remote. As demonstrated by the breadth of studies presented herein, pasteurization is a highly effective virus inactivation step that provides an effective and robust safety measure against both known and emerging enveloped and nonenveloped viruses.