Last updated on 30-4-2024 by Wim Van Molle
Peer reviewed scientific article
English
SCIENSANO
Authors
Corti, Nicoletta; Chiu, Christopher; Cox, Rebecca J; Demont, Clarisse; Devaster, Jeanne-Marie; Engelhardt, Othmar G; Gorringe, Andrew; Hassan, Khaole; Hoefnagel, Marcel; Kamerling, Ingrid; Krut, Oleg; Lane, Chelsea; Liebers, Reinhard; Luke, Catherine; Wim Van Molle; Morel, Sandra; Neels, Pieter; Roestenberg, Meta; Rubbrecht, Michelle; Klaas Smits, Wiep; Stoughton, Daniel; Talaat, Kawsar; Vehreschild, Maria J G T; Wildfire, Adrian; Meln, Irina; Olesen, Ole FKeywords
Abstract:
Within the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 technical white paper “Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents for Use in Human Infection Models” (published by hVIVO, Wellcome Trust, HIC-Vac consortium members). Where those recommendation…