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Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial

Christopher W J McChalicher1, Mary-Jane Lombardo1, Sahil Khanna2

  • 1Seres Therapeutics, Cambridge, Massachusetts, USA.

The Journal of Infectious Diseases
|August 4, 2023
PubMed
Abstract

Insights

Manufacturing fecal microbiota spores live (VOS) involves rapid bacterial inactivation, significantly reducing safety risks associated with fecal microbiota transplants for recurrent Clostridioides difficile infection.

Area of Science:

  • Microbiology
  • Gastroenterology
  • Pharmaceutical Manufacturing

Background:

  • Fecal microbiota transplant (FMT) prevents recurrent Clostridioides difficile infection (rCDI).
  • Minimally processed stool poses safety risks due to potential pathogen transmission.
  • Fecal microbiota spores, live (VOS) is an oral therapeutic derived from Firmicutes spores.

Purpose of the Study:

  • To describe the manufacturing process for VOS.
  • To evaluate the efficacy of VOS manufacturing in inactivating bacteria.
  • To support the safety profile of VOS for rCDI treatment.

Main Methods:

  • Bacterial inactivation kill curves were generated.
  • Ethanol exposure was used to treat 4 model organisms in process intermediates.
  • Rapid lysis and log reduction factors were measured.

Main Results:

  • Bacterial log reduction factors ranged from 6.5 to 7.4 log10.
  • Rapid lysis of spiked organisms occurred within 30 seconds.
  • Demonstrated substantial and rapid inactivation of representative organisms.

Conclusions:

  • VOS manufacturing processes significantly reduce bacterial contamination risks.
  • The described methods support the safety of VOS as a therapeutic for rCDI.
  • Rapid and substantial bacterial inactivation is a key benefit of the VOS manufacturing process.
Keywords:
Clostridioides difficile infectionmicrobiomemicrobiome therapeutic

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