Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD
Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. Retention is mainly a function of size; however, the shape of the pathogen may a...
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| Veröffentlicht in: | Biologicals 2014-09, Vol.42 (5), p.290-293 |
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| creator | Jorba, Nuria Shitanishi, Kenneth T. Winkler, Clint J. Herring, Steven W. |
| description | Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. Retention is mainly a function of size; however, the shape of the pathogen may also influence retention. The ability of the Viresolve® Pro nanofilter to remove different sized viruses during the manufacture of a Coagulation Factor IX (Alphanine® SD) was studied at varying ionic strength, a process condition with the potential to affect virus shape and, hence, virus retention. Eight viruses were tested in a scale-down of the nanofiltration process. Five of the viruses (EMCV, Reo, BVDV, HIV, PRV) were nanofiltered at normal sodium processing conditions and three (PPV, HAV and WNV) were nanofiltered at higher and lower sodium. Representative Reduction Factors for all viruses were ≥4.50 logs and removal was consistent over a wide range of ionic strength. |
| doi_str_mv | 10.1016/j.biologicals.2014.06.002 |
| format | Article |
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Representative Reduction Factors for all viruses were ≥4.50 logs and removal was consistent over a wide range of ionic strength.</description><subject>AlphaNine® SD</subject><subject>Biological Products - isolation & purification</subject><subject>Drug Contamination - prevention & control</subject><subject>Factor IX</subject><subject>Factor IX - isolation & purification</subject><subject>Humans</subject><subject>Ion strength</subject><subject>Micropore Filters</subject><subject>Nanofiltration</subject><subject>Nanotechnology</subject><subject>Osmolar Concentration</subject><subject>Particle Size</subject><subject>Ultrafiltration - methods</subject><subject>Viral safety</subject><subject>Virus removal</subject><subject>Viruses - isolation & purification</subject><subject>Viruses - ultrastructure</subject><issn>1045-1056</issn><issn>1095-8320</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEtOHDEQQK0oKBCSK0Rml013XHZ_7CUayEdCsAAhdpbbXR486mkPtnukuRSH4GT0aEjEMqsqlV79HiFnwEpg0PxYlZ0PQ1h6a4ZUcgZVyZqSMf6BnABTdSEFZx_3eVUXwOrmmHxOacUYQNVWn8gxr5RSTLIT8nDv45RoxHXYmoFaszHW5x01mW5N3PlxSX0YvaUpRxyX-ZH2U9xXRzMG54ccTZ4BGhw9HzaP5tqP-PJMby--kCM3X4df3-Ipuft5ebf4XVzd_PqzOL8qrGjbXEip0NYgrBAVsxLBuqbjjqtWgKoFolKuc9woAX3HhYXOVVLKTjjJW4vilHw_jN3E8DRhynrtk8VhMCOGKWmoGwCuhGhnVB1QG0NKEZ3eRL-en9TA9N6rXul3XvXeq2aNnr3Ovd_e1kzdGvt_nX9FzsDiAOD869Zj1Ml6HC32PqLNug_-P9a8An2pkRA</recordid><startdate>201409</startdate><enddate>201409</enddate><creator>Jorba, Nuria</creator><creator>Shitanishi, Kenneth T.</creator><creator>Winkler, Clint J.</creator><creator>Herring, Steven W.</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8470-7713</orcidid></search><sort><creationdate>201409</creationdate><title>Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD</title><author>Jorba, Nuria ; Shitanishi, Kenneth T. ; Winkler, Clint J. ; Herring, Steven W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c377t-889ec513c3340c8e1cf6b2f29731953ee99fbf2a931db23c1bf4888b3f827ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>AlphaNine® SD</topic><topic>Biological Products - isolation & purification</topic><topic>Drug Contamination - prevention & control</topic><topic>Factor IX</topic><topic>Factor IX - isolation & purification</topic><topic>Humans</topic><topic>Ion strength</topic><topic>Micropore Filters</topic><topic>Nanofiltration</topic><topic>Nanotechnology</topic><topic>Osmolar Concentration</topic><topic>Particle Size</topic><topic>Ultrafiltration - methods</topic><topic>Viral safety</topic><topic>Virus removal</topic><topic>Viruses - isolation & purification</topic><topic>Viruses - ultrastructure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jorba, Nuria</creatorcontrib><creatorcontrib>Shitanishi, Kenneth T.</creatorcontrib><creatorcontrib>Winkler, Clint J.</creatorcontrib><creatorcontrib>Herring, Steven W.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Biologicals</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jorba, Nuria</au><au>Shitanishi, Kenneth T.</au><au>Winkler, Clint J.</au><au>Herring, Steven W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD</atitle><jtitle>Biologicals</jtitle><addtitle>Biologicals</addtitle><date>2014-09</date><risdate>2014</risdate><volume>42</volume><issue>5</issue><spage>290</spage><epage>293</epage><pages>290-293</pages><issn>1045-1056</issn><eissn>1095-8320</eissn><abstract>Nanofiltration is incorporated into the manufacturing processes of many protein biopharmaceuticals to enhance safety by providing the capacity to retain pathogens while allowing protein drugs to pass through the filter. 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| identifier | ISSN: 1045-1056 |
| ispartof | Biologicals, 2014-09, Vol.42 (5), p.290-293 |
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| language | eng |
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| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | AlphaNine® SD Biological Products - isolation & purification Drug Contamination - prevention & control Factor IX Factor IX - isolation & purification Humans Ion strength Micropore Filters Nanofiltration Nanotechnology Osmolar Concentration Particle Size Ultrafiltration - methods Viral safety Virus removal Viruses - isolation & purification Viruses - ultrastructure |
| title | Virus removal capacity at varying ionic strength during nanofiltration of AlphaNine® SD |
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