Manufacture of <i>Clostridioides difficile</i> Spores for Experimental Infection of Human Volunteers
Although there are no clear standardized international guidelines for challenge material production, we demonstrate that it is feasible to produce C difficile human challenge material for small-scale application in CHIM trials. This application of GMP principles to an unconventional production process of a bacterial spore-forming anaerobic challenge agent is an example for the production of challenge material as described in the auxiliary medicinal product guidelines of the European Medicines Agency and the US Food and Drug Administration.
Authors
- M. Y. Eileen C. van der Stoep (ORCID: https://orcid.org/0000-0001-7643-8592)
- A Hensen (ORCID: https://orcid.org/0009-0000-0987-8301)
- Céline Harmanus (ORCID: https://orcid.org/0000-0002-5328-3273)
- Laura Pattacini (ORCID: https://orcid.org/0000-0003-1702-4781)
- Anoecim Robecca Geelen
- Wiep Klaas Smits (ORCID: https://orcid.org/0000-0002-7409-2847)
- Meta Roestenberg (ORCID: https://orcid.org/0000-0002-5052-2830)
- Pauline Meij (ORCID: https://orcid.org/0000-0003-3370-9932)
- Inge M. van Amerongen-Westra (ORCID: https://orcid.org/0009-0009-3271-495X)
- Ed J. Kuijper (ORCID: https://orcid.org/0000-0001-5726-2405)
- P Schipper (ORCID: https://orcid.org/0009-0008-2402-0897)
- Christine Voorvelt (ORCID: https://orcid.org/0009-0008-4922-583X)
- Maryam El Hamdioui
Institutions
- Leiden University Medical Center (NL)
Publication Details
- Journal
- The Journal of Infectious Diseases
- Published
- 2025-12-03
- DOI
- https://doi.org/10.1093/infdis/jiaf612
- Primary Topic
- Clostridium difficile and Clostridium perfringens research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Federation of Pharmaceutical Industries and Associations
- European Commission