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Hamostaseologie 1995; 15(03): 171-178
DOI: 10.1055/s-0038-1655307
Aus der forschenden Industrie/Pharmaceutical Research
Schattauer GmbH

Nanofiltration bei der Herstellung des PPSB-Konzentrates Beriplex® P/N

Erhöhung der Virus-Eliminierungskapazität unter Beibehaltung der Produktqualität
J. Römisch
1   Behringwerke AG, Marburg
,
W. List
1   Behringwerke AG, Marburg
,
D. Bernhardt
1   Behringwerke AG, Marburg
,
K.-H. Diehl
1   Behringwerke AG, Marburg
,
A. Gröner
1   Behringwerke AG, Marburg
,
B. Hein
1   Behringwerke AG, Marburg
,
H.-G. Müller
1   Behringwerke AG, Marburg
,
T. Nowak
1   Behringwerke AG, Marburg
,
H. Ronneberger
1   Behringwerke AG, Marburg
,
E. Schüler
1   Behringwerke AG, Marburg
,
T. Weimer
1   Behringwerke AG, Marburg
› Institutsangaben
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Publikationsverlauf

Publikationsdatum:
26. Juni 2018 (online)

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Zusammenfassung

Nanofiltration, bestehend aus der Kombination von Planova® 75 nm/35 nm Filtern, ist in den Produktionsprozeß des PPSB-Konzentrates Beriplex® P/N integriert. Abreicherungsfaktoren der mit umhüllten Viren versetzten Intermediärprodukte von mehr als 7,2 log10 für HSV-1, mehr als 7,3 log10 für HIV-1, von 3,8 log10 für BVDV und von 4,3 log10 für HBV wurden durch die Filtration erzielt. Durch das PPSB-Reinigungsverfahren, die Pasteurisierung und die Nanofiltration wird ein kumulierter Virusabreicherungsfaktor von mindestens 15 log10 für in Zellkultur titrierbare Viren erzielt. Durch fünf konsekutive Aufarbeitungen im Produktionsmaßstab parallel mit/ohne Nanofiltration wurde die Reproduzierbarkeit und Beibehaltung der Produktqualität gezeigt. Die Einführung der Nanofiltration führte zu keinen nachteiligen Auswirkungen auf Beriplex® P/N; das Produktprofil blieb erhalten.

Schlüsselwörter

Nanofiltration - Virusreduktion - PPSB-Konzentrat - Beriplex® P/N - Produktqualität
 

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