[Nanofiltration in production of Beriplex P/N: increasing the capacity of virus elimination while maintaining product quality].
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.
Römisch
J
J
Centeon Pharma GmbH, Marburg/Lahn, Deutschland.
Gröner
A
A
Bernhardt
D
D
Diehl
K H
KH
Hein
B
B
List
W
W
Müller
H G
HG
Nowak
T
T
Ronneberger
H
H
Schüler
E
E
Weimer
T
T
Hilfenhaus
J
J
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*
D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates
Nanofiltration bei der Herstellung von Beriplex P/N: Erhöhung der Kapazität zur Viruseliminierung unter Beibehaltung der Produktqualität.