Nanofiltration in production of Beriplex P/N: increasing the capacity of virus elimination while maintaining product quality
Römisch, J.; Gröner, A.; Bernhardt, D.; Diehl, K.H.; Hein, B.; List, W.; Müller, H.G.; Nowak, T.; Ronneberger, H.; Schüler, E.; Weimer, T.; Hilfenhaus, J.
Beitrage Zur Infusionstherapie und Transfusionsmedizin 33: 220-224
1996
ISSN/ISBN: 1023-2028 PMID: 8974698 Document Number: 7189
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.
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