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Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.
- Source :
- Journal of Infectious Diseases; 11/15/2023, Vol. 228 Issue 10, p1452-1455, 4p
- Publication Year :
- 2023
-
Abstract
- Background Although fecal microbiota transplant has been used to prevent recurrent Clostridioides difficile infection (rCDI), documented pathogen transmissions highlight inherent safety risks of minimally processed stool. We describe manufacturing processes for fecal microbiota spores, live (VOWST; VOS, formerly SER-109), a microbiota-based oral therapeutic of Firmicutes spores. Methods Bacterial inactivation kill curves were obtained after ethanol exposure for 4 model organisms spiked into process intermediates. Results Bacterial log reduction factors ranged from 6.5 log<subscript>10</subscript> to 7.4 log<subscript>10</subscript> and lysis of spiked organisms occurred rapidly within 30 seconds. Conclusions These experiments demonstrate substantial and rapid inactivation of representative organisms, supporting the potential benefit of VOS manufacturing processes to mitigate risk. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00221899
- Volume :
- 228
- Issue :
- 10
- Database :
- Complementary Index
- Journal :
- Journal of Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 173587445
- Full Text :
- https://doi.org/10.1093/infdis/jiad298