Biesert L, Lemon S, Suhartono H, Wang L, Rübsamen H
Chemotherapeutisches Forschungsinstitut Georg-Speyer-Haus, Frankfurt am Main, Germany.
Blood Coagul Fibrinolysis. 1995 Jul;6 Suppl 2:S48-54. doi: 10.1097/00001721-199506002-00011.
The inactivation of both transfusion-relevant and model viruses by modified pasteurization has been evaluated following the established guidelines of the European Union Committee for Proprietary Medical Products Ad Hoc Working Party on Biotechnology/Pharmacy. This heat treatment in solution for 10 h at 63 degrees C was introduced into the manufacturing process of OCTAVI, a very high purity factor VIII concentrate stabilized by von Willebrand factor. It could be demonstrated that both enveloped (human immunodeficiency virus, herpes simplex virus, pseudorabies virus) and non-enveloped viruses (poliovirus, coxsackievirus, hepatitis A virus) were inactivated by this heating step with an efficacy of greater than 4.5 log10 TCID50. The combination of the solvent/detergent step already used in the manufacture with this modified pasteurization leads to a double virus-inactivated factor VIII concentrate (OCTAVI SDPlus) with a viral safety distinctly superior to monoinactivated products.
按照欧盟专利医疗产品委员会生物技术/药学特别工作组既定指南，已对改良巴氏灭菌法使输血相关病毒和模型病毒失活的情况进行了评估。这种在63摄氏度下于溶液中进行10小时的热处理被引入到OCTAVI的生产工艺中，OCTAVI是一种由血管性血友病因子稳定的超高纯度凝血因子VIII浓缩物。可以证明，包膜病毒（人类免疫缺陷病毒、单纯疱疹病毒、伪狂犬病病毒）和非包膜病毒（脊髓灰质炎病毒、柯萨奇病毒、甲型肝炎病毒）在此加热步骤中均被灭活，灭活效力大于4.5 log10 TCID50。生产中已使用的溶剂/去污剂步骤与这种改良巴氏灭菌法相结合，产生了一种双重病毒灭活的凝血因子VIII浓缩物（OCTAVI SDPlus），其病毒安全性明显优于单一病毒灭活产品。
