Ma Hailun, Khan Arifa S
Laboratory of Retroviruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.
PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):685-9. doi: 10.5731/pdajpst.2011.00843.
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 detection of known and novel viruses is important for cell substrate and vaccine safety. A major challenge is detection of latent viruses such as endogenous retroviruses and oncogenic DNA viruses. We have evaluated activation of endogenous retroviruses in a Vero cell line using chemical induction and various conventional and emerging methods for virus detection and characterization. In addition, infectivity studies were done to determine whether any induced virus particles were replication competent. This approach may be used for enhancing vaccine safety by assessing the presence of potential chemically-inducible, latent viruses in cell substrates to be used for vaccine manufacture.
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) 检测已知和新型病毒对于细胞基质和疫苗安全至关重要。一个主要挑战是检测潜伏病毒,如内源性逆转录病毒和致癌DNA病毒。我们使用化学诱导以及各种传统和新兴的病毒检测与表征方法,评估了Vero细胞系中内源性逆转录病毒的激活情况。此外,还进行了感染性研究,以确定任何诱导产生的病毒颗粒是否具有复制能力。这种方法可用于通过评估用于疫苗生产的细胞基质中潜在的化学诱导性潜伏病毒的存在来提高疫苗安全性。