Kolman J L
Department of Genomics, BioReliance Corporation, Rockville, MD, 20850, USA.
PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):663-7. doi: 10.5731/pdajpst.2011.00836.
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) The rate at which unknown adventitious agents are being discovered is accelerating. The ability to mitigate this risk begins with detection. Several molecular technologies for the detection of adventitious agent genomic signatures are reviewed here. Massively parallel sequencing (MP-Seq) is distinguished by its breadth of coverage. Supported by trained virologists and as part of a quality system, MP-Seq can be an early detection method for safe production of biologics.
会议论文集 《PDA/FDA生物制品中潜在病毒：检测与缓解策略研讨会论文集》，美国马里兰州贝塞斯达；2010年12月1日至3日 客座编辑：阿里法·汗（马里兰州贝塞斯达）、帕特里夏·休斯（马里兰州贝塞斯达）和迈克尔·维贝（加利福尼亚州旧金山） 未知潜在病原体的发现速度正在加快。降低这种风险的能力始于检测。本文综述了几种用于检测潜在病原体基因组特征的分子技术。大规模平行测序（MP-Seq）以其覆盖范围广而著称。在训练有素的病毒学家的支持下，并作为质量体系的一部分，MP-Seq可以成为生物制品安全生产的早期检测方法。
