Virus Inactivation during Preparation of Intravenous Immunoglobulin
Li Zhenping et al (Lanzhou Institute of Biological Products, Lanzhou 730046)
Virus inactivation in the manufacturing of intravenous immunoglobulin (IVIG) was accomplished by treating fraction Ⅱ with solvent-detergent (S/D) mixtures or heating in liquid state for 10 hours at 60℃ (Pasteurization). The efficiency of inactivation was evaluated by using marker viruses. The test results indicated that S/D treatment effectively inactivated lipid enveloped viruses,VSV and Sindbis. The Pasteurization achieved sufficient inactivation of a broad spectrum of marker viruses such as Sindbis,VSV, Echo and Vaccinia. Inactivation treatment did not adversely affect the physicochemical and biological properties of immune globulin. The major characteristics of IVIG prepered with fraction Ⅱ which was treated with S/D or Pasteurization met the requirements of quality control.
【CateGory Index】： R392-33