Khan Arifa S
Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, MD, 20892, USA.
PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):627-33. doi: 10.5731/pdajpst.2011.00831.
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) Adventitious viruses are a major safety concern in biological products. This paper discusses various sources of virus contamination and approaches to develop a comprehensive detection and mitigation strategy for product safety. Additionally, general safety concerns related to adventitious agents in biologics and current testing recommendations by the Center for Biologics Evaluation and Research for demonstrating the absence of adventitious agents in viral vaccines will be presented. The limitations of the conventional assays and the need for and consideration of new technologies for broad detection of novel agents will also be discussed.
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） 潜在病毒是生物制品中的一个主要安全问题。本文讨论了病毒污染的各种来源以及为产品安全制定全面检测和缓解策略的方法。此外，还将介绍与生物制品中潜在因子相关的一般安全问题以及生物制品评估和研究中心目前关于证明病毒疫苗中不存在潜在因子的检测建议。还将讨论传统检测方法的局限性以及广泛检测新型因子所需的新技术和对新技术的考虑。
