News

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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Career opportunities


About IABS PDF Print


The International Alliance for Biological Standardization (IABS) is an independent, non-profit scientific Alliance,  governed by Articles 60-79 of the Swiss Civil code and by its Constitution. Its office is located in Geneva (Switzerland).

IABS has about 250 members in over 50 countries.

Mission

IABS is devoted to the scientific and medical advancement of biologicals, by facilitating communication among those who develop, produce and regulate biological products for human and animal health.

Objectives

  • To provide a unique platform for discussion and the development of consensus positions on contemporary issues related to biologicals;
  • To create an ongoing interface among leaders in clinical and basic research, biological product development, public health, manufacturing and regulation, by organizing scientific conferences and publishing reports of such meetings;
  • To facilitate the establishment of international reference materials and the formulation of international guidance documents for biological substances used in human and veterinary medicine, through its conferences and publications;
  • To promote uniform methods for establishing the international quality of biological products;
  • To encourage research in connection with the characterization, standardization, quality, production, and clinical use of biological products.

History

IABS was founded in Lyon, France, in 1955 by a group of independent experts who believed that such an organization could provide a forum where data could be discussed among scientists working in research, development, production, standardization and regulation of human and veterinary biological products with the ultimate aim of using sound scientific data to improve the quality of biological products and their regulation.

 

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

IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration

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International Alliance for Biological Standardization, Coordinated by Dodet Bioscience