title: Cumulative viral titer reduction demonstrated by sequential challenge of a tangential flow membrane filtration system and a direct flow pleated filter cartridge.
abstract: The efficiency of sequential incorporation of two approaches to virus removal, i.e., tangential flow ultrafiltration using the Omega 300K VR Maximate System, and, direct flow microfiltration using the Ultipor VF grade DV50 virus removal filter, was evaluated using bacteriophage phi 6 in Dulbecco's modified Eagle medium (MEM) as the carrier fluid. A combined log titer reduction value of > 10 was demonstrated, with each step, individually, providing > 4.5 log reduction. Significant improvement in filter life was also demonstrated when the combined system was used. The data suggest that this system may have applications in the manufacture of biologicals and biopharmaceuticals, where there is a requirement for multiple robust methods of virus removal to ensure freedom from endogenous or adventitious viral contamination.
authors.affiliation: Pall Corporation, Scientific and Laboratory Services Department, Port Washington, New York, USA.
authors.forename: H
authors.initials: H
authors.lastname: Aranha-Creado
authors.forename: G J
authors.initials: GJ
authors.lastname: Fennington
mesh_terms: D004340:Drug Contamination / Q000517:prevention & control*; D014462:Ultrafiltration; D014780:Viruses