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Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019
- Source :
- Biologicals. 66:53-61
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Controlled human infection models can be helpful to study pathogenesis and immune responses as a basis for the development of vaccines. In controlled human infection models, human challenge agents are used to infect healthy volunteers, therefore, ethical considerations include that the exposure studies need to be safe and results should be meaningful, e.g. contribute to a better cure. Both in the US and in Europe, the level of Good Manufacturing Practice required is related to the phase of the study ('sliding scale Good Manufacturing Practice'), and, hence, is much more open to speedy drug development than anticipated. Recommendations included: the development of guidelines for human challenge agents; a focus on strain selection, in particular with regard to strain infectivity, stability and purity; the use of whole genome sequencing; a reference repository of challenge agents, the need for early exchange with regulators to ensure acceptability of strain selection and manufacturing for later drug development; sharing of models and challenge agents.
- Subjects :
- 0301 basic medicine
Pharmacology
General Immunology and Microbiology
media_common.quotation_subject
Bioengineering
General Medicine
Applied Microbiology and Biotechnology
Sliding scale
03 medical and health sciences
030104 developmental biology
0302 clinical medicine
Drug development
Risk analysis (engineering)
Healthy volunteers
Quality (business)
Good manufacturing practice
030212 general & internal medicine
Business
Biotechnology
media_common
Subjects
Details
- ISSN :
- 10451056
- Volume :
- 66
- Database :
- OpenAIRE
- Journal :
- Biologicals
- Accession number :
- edsair.doi...........d9335536193ffb1f5e838be489c7aa8e
- Full Text :
- https://doi.org/10.1016/j.biologicals.2020.04.005