کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8962000 | 1646531 | 2018 | 16 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Report of the international conference on next generation sequencing for adventitious virus detection in biologicals
ترجمه فارسی عنوان
گزارش کنفرانس بین المللی توالی نسل بعدی برای تشخیص ویروس های احتمالی در زیست شناسی
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کلمات کلیدی
PEIHTSFDACBERAPHISAphANIBSCNGSUSDAGlaxoSmithKlineGSKU.S. Food and Drug Administration - اداره غذا و داروی ایالات متحدهCell substrate - بستر سلولیHealth Canada - بهداشت کاناداBioinformatics - بیوانفورماتیک Biotherapeutics - بیوتراپیBiologics - بیولوژیکNext-generation sequencing - تعیین توالی نسل بعدیHigh-throughput sequencing - توالی انتخابی بالاHigh throughput sequencing - توالی انتخابی بالاNext generation sequencing - توالی نسل بعدیUnited States Department of Agriculture - دپارتمان کشاورزی ایالات متحدهWorld Health Organization - سازمان بهداشت جهانیVaccines - واکسنWHO - که
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوشیمی، ژنتیک و زیست شناسی مولکولی (عمومی)
چکیده انگلیسی
A fundamental aspect of biological product safety is to assure absence of adventitious agents in the final product. Next-generation or high-throughput sequencing (NGS/HTS) has recently demonstrated detection of viruses that were previously missed using the recommended routine assays for adventitious agent testing of biological products. This meeting was co-organized by the International Alliance for Biological Standardization (IABS) and the U.S. Food and Drug Administration (FDA) to assess the current status and discuss the readiness of NGS for adventitious virus detection in biologics. The presentations included efforts for standardization, case studies on applications in biologics, comparison with routine virus detection assays, and current regulatory thinking. Participants identified the need for standard reference reagents, well-annotated databases, large data storage and transfer capacity, personnel with relevant expertise, particularly in bioinformatics; and harmonization of international regulations for testing biologic products and reagents used for their manufacturing. We hope this meeting summary will be of value to regulators and industry for considerations of NGS applications for adventitious virus detection in biologics.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Biologicals - Volume 55, September 2018, Pages 1-16
Journal: Biologicals - Volume 55, September 2018, Pages 1-16
نویسندگان
Arifa S. Khan, Luca Benetti, Johannes Blumel, Dieter Deforce, William M. Egan, Ivana Knezevic, Philip R. Krause, Laurent Mallet, Dietmar Mayer, Philip D. Minor, Pieter Neels, Guanhua Wang,