Effectiveness of nanofiltration in removing small non-enveloped viruses from three different plasma-derived products.
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.
Menconi
M C
MC
Kedrion S.p.A. Research Centre, Castelvecchio Pascoli (LU), University of Pisa, Pisa, Italy.
Maggi
F
F
Zakrzewska
K
K
Salotti
V
V
Giovacchini
P
P
Farina
C
C
Andreoli
E
E
Corcioli
F
F
Bendinelli
M
M
Azzi
A
A
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
D001798:Blood Proteins