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
{"title":"[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]。","authors":"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","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":79439,"journal":{"name":"Beitrage zur Infusionstherapie und Transfusionsmedizin = Contributions to infusion therapy and transfusion medicine","volume":"33 ","pages":"220-4"},"PeriodicalIF":0.0000,"publicationDate":"1996-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Nanofiltration in production of Beriplex P/N: increasing the capacity of virus elimination while maintaining product quality].\",\"authors\":\"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\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":79439,\"journal\":{\"name\":\"Beitrage zur Infusionstherapie und Transfusionsmedizin = Contributions to infusion therapy and transfusion medicine\",\"volume\":\"33 \",\"pages\":\"220-4\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1996-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Beitrage zur Infusionstherapie und Transfusionsmedizin = Contributions to infusion therapy and transfusion medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Beitrage zur Infusionstherapie und Transfusionsmedizin = Contributions to infusion therapy and transfusion medicine","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
[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.