[Beriplex P/N生产中的纳滤:在保持产品质量的同时提高病毒消除能力]。

J Römisch, A Gröner, D Bernhardt, K H Diehl, B Hein, W List, H G Müller, T Nowak, H Ronneberger, E Schüler, T Weimer, J Hilfenhaus
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引用次数: 0

摘要

为了生产PCC Beriplex P/N,在Beriplex HS的生产过程中引入了纳滤,为清除/灭活病毒提供了一种额外的热处理手段。通过纳滤,大包膜病毒(HSV-1, HIV-1)被完全消除,其因子大于7 log10。中型包膜病毒(HBV, BVDV)被清除的倍数约为4 log10,而小型非包膜病毒(脊髓灰质炎病毒)未被清除。产品轮廓保持不变,未检测到血栓形成活性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[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.

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