International Alliance for Biological Standardization

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Quality Requirements for Challenge Agents

October 22, 2019
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