Viral Safety of Plasma-derived Blood Products. III. Effects of Virus Inactivation by Pasteurization in Human Serum Albumin Concentrates (Sekijyuji Albumin and Sekijyuji Albumin 25)

We investigated virus inactivation by two albumin products (Sekijyuji Albumin® and Sekijyuji Albumin 25® derived from human plasma with heat treatment at 60°C in liquid-phase (pasteurization) using several enveloped and non-enveloped viruses as marker viruses. Enveloped viruses were sindbis virus (SIN), vesicular stomatitis virus (VSV), herpes simplex virus type-1 (HSV-1) and human immunodeficiency virus type-1 (HIV-1). Non-enveloped viruses were polio virus (Polio V) and hepatitis A virus (HAV). The infectivity of all viruses except HAV was lost after 1hr heating, with logarithmic reduction value (LRV) for SIN, VSV, HSV-1, HIV-1 and Polio V of >5.1, >5.7, >4.3, >3.8 and >5.9, respectively. No significant difference in LRVs were observed between the two products. The infectivity of HAV, however, remained at 104.2-5.0 TCID50 even after 10hr heating and LRV stayed in the range of 1.9 to 2.7.