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2nd Next Generation Sequencing
for Adventitious Virus Detection

Meeting objectives
T
his meeting will focus on the current scientific data and knowledge related to the use of next generation sequencing technologies for adventitious virus detection in biological products. Discussions will include ongoing efforts and future needs toward standardization and validation of the technical and bioinformatics steps involved in NGS for its applications in characterization and safety evaluation of biologics, including human and animal vaccines. The meeting will bring together representatives from industry, academia, technology providers, and international regulatory bodies for developing a scientific consensus regarding readiness of NGS for detection of adventitious viruses in biologics.

Scientific Committee

Dieter Deforce, Ghent University / Federal Agency for Medicines and Health Products of Belgium (FAMHP)
Sebastiaan Theuns, Ghent University
Arifa Khan, U.S. Food and Drug Administration (FDA)
Pieter Neels, International Alliance for Biological Standardization (IABS)
Sven Arnouts, Ghent University / PROVAXS
Johannes Blümel, Paul-Ehrlich Institut (PEI)
Bill Egan, Novartis Vaccines & Diagnostics
Carmen Jungbäck, International Alliance for Biological Standardization (IABS)
Ivana Knezevic, World Heath Organization (WHO)
Laurent Mallet, Sanofi Pasteur
Gerald Schumann, Paul-Ehrlich Institut (PEI)
Joseph Victoria, Boehringer-Ingelheim

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Quality of Challenge Agent
An IABS-EU Meeting

Meeting Objectives
One of the proposed tools for faster development of new vaccines is CHIM: Controlled Human Infectious Models. These models can be used for early PoC (Proof of Concept) and as a basis for clinical  “Go/No Go” decisions, in particular if sporadic epidemiology impedes clinical development.
In these models researchers will use a challenge agent: a virus, bacterium or parasite. Frequently questions are raised on the quality of the agent. Should this agent be produced following GMP? What strain-related information is relevant?  Should it be attentuated or resemble the wild type?

These questions will be discussed during this symposium, more information will follow soon

 

 

International Alliance for Biological Standardization


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Contact Info

IABS, Rue de la Vallée, 3
CH-1204 Geneva

Switzerland
+ 41 22 301 10 36
+ 41 22 301 10 37
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