CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

Available guidance documents, such as the International Conference on Harmonization
(ICH) Q5a: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of …

The November 2013 workshop was organized by the Parenteral Drug Association (PDA)
and US Food and Drug Administration (FDA) to provide an open scientific dialogue between …

Testing product and process intermediates alone is helpful, but does not provide a complete
solution to viral safety. This article proposes integrated solutions for systemic and proactive …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

Contamination by viral and microbial agents is a serious risk for biopharmaceuticals
produced by mammalian cell culture processes. In order to effectively mitigate the risk and …

Raw materials are critical components of product manufacture; these include source
materials such as cell substrates, tissues, and biological fluids required for product …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

Biologicals ushered in a new era for treating debilitating and life-threatening illnesses.
According to a Pharmaceutical Research and Manufacturers of America (PhRMA) 2011 …