title: Hepatitis E virus derived from different sources exhibits different behaviour in virus inactivation and/or removal studies with plasma derivatives.
abstract: Hepatitis E virus (HEV) causes viral hepatitis, and is considered a risk factor for blood products. Although some HEV inactivation/removal studies have been reported, detailed investigations of different manufacturing steps as heat treatment, partitioning during cold ethanol fractionation, low pH treatment, and virus filtration have yet to be reported for plasma-derived medicinal products. In this study, human serum- and swine faeces-derived HEVs, with and without detergent treatment, were used. The kinetic patterns of inactivation, log reduction value, or partitioning during the process were evaluated. In addition, the mouse encephalomyocarditis virus (EMCV) and canine and porcine parvoviruses (CPV/PPV) were also evaluated as model viruses for HEV. Small pore size (19 or 15 nm) virus filtration demonstrated effective removal of HEV. Middle pore size (35 nm) virus filtration and 60 °C liquid heating demonstrated moderate inactivation/removal. Ethanol fractionation steps demonstrated limited removal of HEV. Unpurified HEV exhibited different properties than the detergent-treated HEV, and both forms displayed differences when compared with EMCV, CPV, and PPV. Limited or no inactivation of HEV was observed during low pH treatment. Untreated plasma-derived HEV from humans showed different properties compared to that of HEV treated with detergent or derived from swine faeces. Therefore, HEV spike preparation requires more attention.
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan; Department of Virology, Research Institute for Microbial Diseases, Osaka University, Suita, Osaka, Japan; School of Veterinary Medicine, Rakuno Gakuen University, Ebetsu, Hokkaido, Japan. Electronic address: yunoki-mikihiro@jbpo.or.jp.
authors.forename: Mikihiro
authors.initials: M
authors.lastname: Yunoki
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tanaka
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Kadue
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Takeru
authors.initials: T
authors.lastname: Urayama
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Hattori
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Ideno
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Rie
authors.initials: R
authors.lastname: Furuki
authors.affiliation: R&D Division, Japan Blood Products Organization(1), Tokyo, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Sakai
authors.affiliation: School of Veterinary Medicine, Rakuno Gakuen University, Ebetsu, Hokkaido, Japan.
authors.forename: Katsuro
authors.initials: K
authors.lastname: Hagiwara
authors.affiliation: Department of Virology, Research Institute for Microbial Diseases, Osaka University, Suita, Osaka, Japan.
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Ikuta
mesh_terms: D000818:Animals; D004203:Disinfection / Q000379:methods*; D004285:Dogs; D005260:Female; D016751:Hepatitis E; D016752:Hepatitis E virus / Q000737:chemistry* / Q000302:isolation & purification*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D051379:Mice; D010949:Plasma / Q000821:virology*; D013552:Swine; D038301:Virus Inactivation
keywords: Ethanol fractionation; HEV; Liquid-heating; Low pH; Partitioning; Plasma derivatives