| Proceedings of the 2009 Viral Clearance Symposium. | |
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MedLine Citation:
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PMID: 21516942 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The 2009 Viral Clearance Symposium (Indianapolis, IN, USA) was held to interactively discuss methods for virus removal and inactivation during biopharmaceutical manufacture. Its origin was the result of worldwide regulatory and industry recognition that challenges, gaps, and opportunities for improvement exist, which if formally addressed could benefit the field as a whole. The symposium began with presentations by the FDA (USA) and the Paul Ehrlich Institute (PEI, Germany), which highlighted viral clearance study information reported in regulatory submissions. In these two presentations, and a subsequent series of brief industry presentations covering various unit operations, it was made clear that many unit operations are quite effective in clearing viruses. This was particularly true of low pH inactivation, anion exchange chromatography, and virus filtration. Moreover, the follow-up discussions at the end of each session, and the wrap-up at the end of the symposium, aimed to synthesize the regulatory data mining knowledge base with the industry-generated data. The symposium also revealed a number of unknowns in the field which were defined and prioritized, and served as potential action items for future experimental studies. |
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Authors:
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- |
Publication Detail:
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Type: Congresses; Overall; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Developments in biologicals Volume: 133 ISSN: 1424-6074 ISO Abbreviation: Dev Biol (Basel) Publication Date: 2010 |
Date Detail:
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Created Date: 2011-04-26 Completed Date: 2011-05-31 Revised Date: 2011-06-16 |
Medline Journal Info:
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Nlm Unique ID: 100940058 Medline TA: Dev Biol (Basel) Country: Switzerland |
Other Details:
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Languages: eng Pagination: 3-101 Citation Subset: IM |
Affiliation:
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Merck Research Laboratories, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Biotechnology Chromatography / methods Chromatography, Ion Exchange Detergents / pharmacology Drug Contamination / prevention & control Drug Industry Filtration / methods Humans Hydrogen-Ion Concentration Staphylococcal Protein A United States United States Food and Drug Administration Virus Inactivation / drug effects Viruses / isolation & purification* |
| Chemical | |
Reg. No./Substance:
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0/Detergents; 0/Staphylococcal Protein A |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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