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

From an industrial perspective, the conventional in vitro and in vivo assays used for
detection of viral contaminants have shown their limitations, as illustrated by the unfortunate …

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

In January 2010, porcine circovirus type 1 (PCV1) DNA was unexpectedly detected in the
oral live-attenuated human rotavirus vaccine, Rotarix™(GlaxoSmithKline [GSK] Vaccines) by …

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 …

ABSTRACT Purpose The Food and Drug Administration temporarily suspended monovalent
rotavirus vaccine (RV1) use following discovery of contamination with porcine circovirus …

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

Safety and quality are important issues for vaccines. Whereas reversion to virulence poses a
safety risk with live attenuated vaccines, the potential for the presence of adventitious agents …

The quality and safety of commercial vaccines have a profound importance. Contrary to all
precautions and efforts the use of biological material in vaccine development and production …

DNA from porcine circovirus type 1 (PCV1) and 2 (PCV2) has recently been detected in two
vaccines against rotaviral gastroenteritis from manufacturers A and B. We investigated if …