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@article{Corti:2024:10.1016/j.biologicals.2024.101746,
author = {Corti, N and Chiu, C and Cox, RJ and Demont, C and Devaster, J-M and Engelhardt, OG and Gorringe, A and Hassan, K and Hoefnagel, M and Kamerling, I and Krut, O and Lane, C and Liebers, R and Luke, C and Van, Molle W and Morel, S and Neels, P and Roestenberg, M and Rubbrecht, M and Klaas, Smits W and Stoughton, D and Talaat, K and Vehreschild, MJGT and Wildfire, A and Meln, I and Olesen, OF},
doi = {10.1016/j.biologicals.2024.101746},
journal = {Biologicals},
title = {Regulatory workshop on challenge strain development and GMP manufacture - a stakeholder meeting report},
url = {http://dx.doi.org/10.1016/j.biologicals.2024.101746},
volume = {85},
year = {2024}
}
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TY  - JOUR
AB  - 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 recommendations cannot be met, regulators advise following the "Principles of GMP" until definitive guidelines are available. Sourcing wild-type virus isolates is a significant challenge for developers. Still, it is preferred over reverse genetics challenge strains for several reasons, including implications and regulations around genetically modified organisms (GMOs). Official informed consent guidelines for collecting isolates are needed, and the characterisation of these isolates still presents risks and uncertainty. Workshop topics included ethics, liability, standardised clinical endpoints, selection criteria, sharing of challenge agents, and addressing population heterogeneity concerning vaccine response and clinical course. The organisers are confident that the workshop discussions will contribute to advancing ethical, safe, and high-quality CHIM studies of influenza, RSV and C. difficile, including adequate regulatory frameworks.
AU  - Corti,N
AU  - Chiu,C
AU  - Cox,RJ
AU  - Demont,C
AU  - Devaster,J-M
AU  - Engelhardt,OG
AU  - Gorringe,A
AU  - Hassan,K
AU  - Hoefnagel,M
AU  - Kamerling,I
AU  - Krut,O
AU  - Lane,C
AU  - Liebers,R
AU  - Luke,C
AU  - Van,Molle W
AU  - Morel,S
AU  - Neels,P
AU  - Roestenberg,M
AU  - Rubbrecht,M
AU  - Klaas,Smits W
AU  - Stoughton,D
AU  - Talaat,K
AU  - Vehreschild,MJGT
AU  - Wildfire,A
AU  - Meln,I
AU  - Olesen,OF
DO  - 10.1016/j.biologicals.2024.101746
PY  - 2024///
SN  - 1045-1056
TI  - Regulatory workshop on challenge strain development and GMP manufacture - a stakeholder meeting report
T2  - Biologicals
UR  - http://dx.doi.org/10.1016/j.biologicals.2024.101746
UR  - https://www.ncbi.nlm.nih.gov/pubmed/38309984
UR  - https://www.sciencedirect.com/science/article/pii/S1045105624000034
VL  - 85
ER  -
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