Pruss A, Kao M, Kiesewetter H, von Versen R, Pauli G
Institute for Transfusion Medicine, Tissue Bank, University Hospital Charité, Medical Faculty of Humboldt-University Berlin, Germany.
Biologicals. 1999 Sep;27(3):195-201. doi: 10.1006/biol.1999.0177.
The aim of this study was to validate the virus-inactivating/eliminating capacity of the manufacturing process of spongiosa cuboids. Both the sterilization step with peracetic acid (PAA)/ethanol and the defatting step of bones with chloroform/methanol (2:1, v/v) were investigated. Relevant enveloped, non-enveloped, and model viruses belonging to different virus families were included in the investigation: human immunodeficiency virus type 2 (HIV-2), hepatitis A virus (HAV), poliovirus (PV-1), pseudorabies virus (PRV), porcine parvovirus (PPV), and bovine virus diarrhoea virus (BVDV). Treatment of virus-spiked spongiosa cuboids for 4 hours at room temperature (RT) with 1% PAA/24% ethanol (PES) efficiently inactivated most viruses. Titres were reduced by more than 4 log(10)with the exception of HAV. The defatting step with chloroform/methanol reduced HAV titres by a factor of >/=7.0 log(10). From these results it can be concluded that the treatment of spongiosa cuboids with (i) chloroform/methanol and (ii) 1% PAA/24% ethanol solution leads to a virus-safe medicinal product.
本研究的目的是验证海绵骨块生产工艺的病毒灭活/去除能力。研究了过氧乙酸（PAA）/乙醇的灭菌步骤以及用氯仿/甲醇（2:1，v/v）对骨头进行脱脂的步骤。属于不同病毒科的相关包膜病毒、无包膜病毒和模型病毒被纳入研究：2型人类免疫缺陷病毒（HIV-2）、甲型肝炎病毒（HAV）、脊髓灰质炎病毒（PV-1）、伪狂犬病病毒（PRV）、猪细小病毒（PPV）和牛病毒性腹泻病毒（BVDV）。用1% PAA/24%乙醇（PES）在室温（RT）下对加有病毒的海绵骨块处理4小时可有效灭活大多数病毒。除HAV外，病毒滴度降低超过4个对数（10）。用氯仿/甲醇进行的脱脂步骤使HAV滴度降低了≥7.0个对数（十）。从这些结果可以得出结论，用（i）氯仿/甲醇和（ii）1% PAA/24%乙醇溶液处理海绵骨块可得到病毒安全的药用产品。
