Application of quality by design in the control of adventitious viruses: gaps in current processes in the prevention of virus contaminants.
作者信息
Cherney Barry
机构信息
Deputy Director, Division of Therapeutic Proteins, CDER, FDA.
出版信息
PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):754-66. doi: 10.5731/pdajpst.2011.00849.
PMID:22294609
Abstract
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).
摘要
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