Nicoletta Corti, Christopher Chiu, Rebecca J Cox, Clarisse Demont, Jeanne-Marie Devaster, Othmar G Engelhardt, Andrew Gorringe, Khaole Hassan, Marcel Hoefnagel, Ingrid Kamerling, Oleg Krut, Chelsea Lane, Reinhard Liebers, Catherine Luke, Wim Van Molle, Sandra Morel, Pieter Neels, Meta Roestenberg, Michelle Rubbrecht, Wiep Klaas Smits, Daniel Stoughton, Kawsar Talaat, Maria J G T Vehreschild, Adrian Wildfire, Irina Meln, Ole F Olesen
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)...
February 2, 2024: Biologicals: Journal of the International Association of Biological Standardization