title: [Nanofiltration in production of Beriplex P/N: increasing the capacity of virus elimination while maintaining product quality].
abstract: For the manufacture of the PCC Beriplex P/N, nanofiltration was introduced into the production process of Beriplex HS providing an additional means to heat treatment for the clearance/inactivation of viruses. By nanofiltration, large enveloped viruses (HSV-1, HIV-1) were completely eliminated by a factor of more than 7 log10. While medium-sized enveloped viruses (HBV, BVDV) were cleared by a factor of approximately 4 log10, small non-enveloped viruses (poliovirus) were not removed. The product profile remained, no thrombogenic activities were detected.
authors.affiliation: Centeon Pharma GmbH, Marburg/Lahn, Deutschland.
authors.forename: J
authors.initials: J
authors.lastname: Römisch
authors.forename: A
authors.initials: A
authors.lastname: Gröner
authors.forename: D
authors.initials: D
authors.lastname: Bernhardt
authors.forename: K H
authors.initials: KH
authors.lastname: Diehl
authors.forename: B
authors.initials: B
authors.lastname: Hein
authors.forename: W
authors.initials: W
authors.lastname: List
authors.forename: H G
authors.initials: HG
authors.lastname: Müller
authors.forename: T
authors.initials: T
authors.lastname: Nowak
authors.forename: H
authors.initials: H
authors.lastname: Ronneberger
authors.forename: E
authors.initials: E
authors.lastname: Schüler
authors.forename: T
authors.initials: T
authors.lastname: Weimer
authors.forename: J
authors.initials: J
authors.lastname: Hilfenhaus
mesh_terms: D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D017848:Blood-Borne Pathogens; D001908:Diarrhea Viruses, Bovine Viral / Q000302:isolation & purification; D015497:HIV-1 / Q000302:isolation & purification; D006515:Hepatitis B virus / Q000302:isolation & purification; D018259:Herpesvirus 1, Human / Q000302:isolation & purification; D006801:Humans; D017955:Poliovirus / Q000302:isolation & purification; D014780:Viruses / Q000302:isolation & purification*
chemical_list: D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates
vernacular_title: Nanofiltration bei der Herstellung von Beriplex P/N: Erhöhung der Kapazität zur Viruseliminierung unter Beibehaltung der Produktqualität.