Dataset Information

Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.

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 log10 to 7.4 log10 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.

SUBMITTER: McChalicher CWJ

PROVIDER: S-EPMC10640771 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.

McChalicher Christopher W J CWJ Lombardo Mary-Jane MJ Khanna Sahil S McKenzie Gregory J GJ Halvorsen Elizabeth M EM Almomani Sanabel S Schuster Brian B Hasson Brooke R BR McGovern Barbara H BH Ege David S DS Auniņš John G JG

The Journal of infectious diseases 20231101 10

<h4>Background</h4>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.<h4>Methods</h4>Bacterial inactivation kill curves were obtained after ethanol exposure for 4 model organisms s ...[more]

PMID: 37540090

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Dataset Information

Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.

Background

Methods

Results

Conclusions

Publications

Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.

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