title: Estimation of efficiency of solvent-detergent method for virus inactivation in the technology of immunoglobulin production on the model of duck hepatitis B virus.
abstract: The virucidal action of solvent tributyl phosphate and detergent sodium cholate used in the production of immunoglobulin for inactivation of viruses with lipid envelope was studied on the model of duck hepatitis B virus. PCR analysis revealed no significant decrease in duck hepatitis B virus DNA concentrations after treatment with solvent/detergent. At the same time, in vivo experiments showed that treatment of duck hepatitis B virus with tributyl phosphate (concentration >0.15%) and sodium cholate (concentration >0.1%) at 37°C for 6 h or longer completely inactivated this model virus added to immunoglobulin solution in concentration 5 log ID50. Duck hepatitis B virus appears to be one of the most acceptable model viruses for validation of virus inactivating technologies in manufacturing human plasma preparations.
authors.affiliation: Branch Office of Microgen Research-and-Production Association, Nizhnii Novgorod Bacterial Medicine Plant ImBio, Ministry of Health, Nizhnii Novgorod; M. P. Chumakov Institute of Poliomyelitis and Viral Encephalitis, Russian Academy of Medical Sciences, Moscow; Microgen Research-and-Production Association, Ministry of Health, Moscow, Russia. karen-kyuregyan@yandex.ru.
authors.forename: N V
authors.initials: NV
authors.lastname: Zubkova
authors.forename: V V
authors.initials: VV
authors.lastname: Anastasiev
authors.forename: K K
authors.initials: KK
authors.lastname: Kyuregyan
authors.forename: M I
authors.initials: MI
authors.lastname: Mikhailov
authors.forename: A K
authors.initials: AK
authors.lastname: Lobastova
authors.forename: I V
authors.initials: IV
authors.lastname: Krasil'nikov
mesh_terms: D000818:Animals; D004202:Disinfectants / Q000494:pharmacology*; D004372:Ducks; D015611:Hepatitis B Virus, Duck / Q000187:drug effects*; D006801:Humans; D007106:Immune Sera / Q000302:isolation & purification; D007074:Immunoglobulin G / Q000302:isolation & purification*; D010755:Organophosphates / Q000494:pharmacology*; D020358:Sodium Cholate / Q000494:pharmacology*; D012996:Solutions; D038301:Virus Inactivation
chemical_list: D004202:Disinfectants; D007106:Immune Sera; D007074:Immunoglobulin G; D010755:Organophosphates; D012996:Solutions; C009524:tributyl phosphate; D020358:Sodium Cholate