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Just Published in the September 2014 issue of Biologicals

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.

Four case studies where an adventitious agent, or a signal suggesting the presence of an agent, was found in a viral vaccine, are presented in this paper. The lessons learned from each event are discussed.

Based in part on those experiences,certain scientific principles have been identified by WHO that should be considered in regulatory risk evaluation if an adventitious agent is found in a marketed vaccine in the future.

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Invitation to Join Brighton Collaboration

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file icon W. Egan_October 31, 2012Tooltip 10/31/2012 Hits: 1144
file icon T. Hayakawa_Nov. 6, 2012Tooltip 12/06/2012 Hits: 1081
file icon Pieter NeelsTooltip 07/04/2014 Hits: 915
file icon Paul-Henri Lambert_Oct. 30, 2012Tooltip 10/30/2012 Hits: 677
file icon John Petricciani_Oct. 30, 2012Tooltip 10/30/2012 Hits: 1573
file icon John C. Petricciani_2014Tooltip 02/04/2014 Hits: 404
file icon Johannes Löwer_Oct. 30, 2012Tooltip 10/30/2012 Hits: 814
file icon Johan VanhemelrijckTooltip 07/04/2014 Hits: 786
file icon Jean-Marie PréaudTooltip 07/04/2014 Hits: 794
file icon James S RobertsonTooltip 09/12/2011 Hits: 1332
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A few words from the President

 

We are now half-way through 2014, and much has happened during these first 6 months.

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Veterinary Scientific Committee

Read more about Alternatives to Antibiotics, Challenges and Solutions in Animal Production

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Now available !

Vaccines and Diagnostics for Transboundary Animal Diseases

International Symposium, Ames, Iowa, September 2012: Proceedings

Editor(s): Roth J.A. (Ames, Iowa) ; Richt J.A. (Manhattan, Kansas); Morozov I.A. (Manhattan, Kansas)


Please use this link to order the book: http://www.karger.com/Book/Home/259868

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