title: Effectiveness of nanofiltration in removing small non-enveloped viruses from three different plasma-derived products.
abstract: The objective of this study was to assess the ability of nanofiltration of albumin solution, prothrombin complex (PTC) and factor IX (FIX) to remove two small, non-enveloped DNA viruses, parvovirus B19 (B19V) and torque teno virus (TTV). Virus removal was investigated with down-scale experiments performed with sequential steps of 35-nm and 15-nm nanofiltrations of products spiked with virus DNA-positive sera. Viral loads were determined by real-time PCRs. The 15-nm nanofiltration removed more than 4.0 B19V log from all the products, TTV was reduced of more than 3.0 log from albumin solution and FIX by 35-nm and 15-nm nanofiltrations, respectively, being viral DNA undetectable after these treatments. Traces of TTV were still found in PTC after the 15-nm nanofiltration. In conclusion, nanofiltration can be efficacious in removing small naked viruses but, since viruses with similar features can differently respond to the treatment, a careful monitoring of large-scale nanofiltration should be performed.
authors.affiliation: Kedrion S.p.A. Research Centre, Castelvecchio Pascoli (LU), University of Pisa, Pisa, Italy.
authors.forename: M C
authors.initials: MC
authors.lastname: Menconi
authors.forename: F
authors.initials: F
authors.lastname: Maggi
authors.forename: K
authors.initials: K
authors.lastname: Zakrzewska
authors.forename: V
authors.initials: V
authors.lastname: Salotti
authors.forename: P
authors.initials: P
authors.lastname: Giovacchini
authors.forename: C
authors.initials: C
authors.lastname: Farina
authors.forename: E
authors.initials: E
authors.lastname: Andreoli
authors.forename: F
authors.initials: F
authors.lastname: Corcioli
authors.forename: M
authors.initials: M
authors.lastname: Bendinelli
authors.forename: A
authors.initials: A
authors.lastname: Azzi
mesh_terms: D001781:Blood Component Removal / Q000379:methods; D001798:Blood Proteins; D006801:Humans; D016732:Parvovirus B19, Human; D022783:Torque teno virus; D014462:Ultrafiltration / Q000379:methods*; D038301:Virus Inactivation
chemical_list: D001798:Blood Proteins