Isabelle Bekeredjian-DingJean Hugues TrouvinHilde DepraetereCarine LaAkamol E. SuvarnapunyaAlan BellAlex MannPauline MeijJeffrey M. BethonyLinda SchellhaasWinfred Badanga NazziwaEric Karikari-BoatengJetsumon Sattabongkot PrachumsriPaula SalmikangasDean SmithPeter StjärnkvistWim Van MolleMarc BaayPieter NeelshVIVO Services LimitedFaculty of Tropical Medicine, Mahidol UniversityP95 CVBAPaul-Ehrlich-InstitutHealth CanadaLeids Universitair Medisch CentrumWalter Reed Army Institute of ResearchThe George Washington UniversityMedical Product Agency SwedenNDA Advisory BoardSciensanoInternational Alliance for Biological StandardizationFood and Drugs AuthorityEuropean Vaccine InitiativeUganda National Council for Science and Technology2022-08-042022-08-042021-11-01Biologicals. Vol.74, (2021), 16-2310958320104510562-s2.0-85119924588https://repository.li.mahidol.ac.th/handle/20.500.14594/75968There is an increasing need to establish quality principles for designing, developing and manufacturing challenge agents as currently these agents are classified differently by various jurisdictions. Indeed, considerations for challenge agent manufacturing vary between countries due to differences in regulatory oversight, the categorization of the challenge agent and incorporation into medicinal/vaccine development processes. To this end, a whitepaper on the guidance has been produced and disseminated for consultation to researchers, regulatory experts and regulatory or advisory bodies. This document is intended to discuss fundamental principles of selection, characterization, manufacture, quality control and storage of challenge agents for international reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, followed by use of qualified methods to test critical steps in the manufacturing process, or the final product itself. These activities are complementary: GMP rules, which intervene only at the time of the routine manufacturing of batches, do not contribute to the proper development and qualification of the candidate product. Some considerations regarding suitability of premises for challenge manufacturing was discussed in the presentation dedicated to “routine manufacturing”.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyChemical EngineeringImmunology and MicrobiologyPharmacology, Toxicology and PharmaceuticsControlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strainArticleSCOPUS10.1016/j.biologicals.2021.09.002