Quality Requirements for Challenge Agents - October 22, 2019

Quality Requirements for Challenge Agents
An IABS-EU Meeting

Read the Meeting Report 

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

View the Agenda

 

International Alliance for Biological Standardization


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