Adventitious agents in viral vaccines: Lessons learned from 4 case studies
نویسندگان
چکیده
منابع مشابه
Adventitious agents in viral vaccines: lessons learned from 4 case studies.
Since the earliest days of biological product manufacture, there have been a number of instances where laboratory studies provided evidence for the presence of adventitious agents in a marketed product. Lessons learned from such events can be used to strengthen regulatory preparedness for the future. We have therefore selected four instances where an adventitious agent, or a signal suggesting t...
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ژورنال
عنوان ژورنال: Biologicals
سال: 2014
ISSN: 1045-1056
DOI: 10.1016/j.biologicals.2014.07.003