Manufacturing Process of SER-109, a Purified Investigational Microbiome Therapeutic, Reduces Risk of Coronavirus Transmission From Donor Stool-Reference-Cited by-同舟云学术

Manufacturing Process of SER-109, a Purified Investigational Microbiome Therapeutic, Reduces Risk of Coronavirus Transmission From Donor Stool

Published:2022-09-01 Issue:9 Volume:9 Page:
ISSN:2328-8957
Container-title:Open Forum Infectious Diseases
language:en
Short-container-title:

Author:

McChalicher Christopher¹,Abdulaziz Ahmad¹,Zhou S Steve²,Lombardo Mary-Jane¹,Hasson Brooke¹,Auniņš John G¹,McGovern Barbara H¹^ORCID,Ege David S¹

Affiliation:

1. Seres Therapeutics , Cambridge, Massachusetts , USA

2. Microbac Laboratories, Inc , Sterling, Virginia , USA

Abstract

Abstract Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may present risk to patients treated with donor-derived microbiome therapies when appropriate manufacturing controls and inactivation processes are lacking. We report that the manufacturing steps for SER-109, a purified investigational microbiome therapeutic developed to reduce risk of Clostridioides difficile recurrence, inactivate porcine epidemic diarrhea virus, a model coronavirus for SARS-CoV-2.

Funder

Seres Therapeutics

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Oncology

Link

https://academic.oup.com/ofid/advance-article-pdf/doi/10.1093/ofid/ofac448/45650165/ofac448.pdf

Reference23 articles.

1. Low cure rates in controlled trials of fecal microbiota transplantation for recurrent Clostridium difficile infection: a systematic review and meta-analysis;Tariq;Clin Infect Dis,2019

2. Drug-resistant E. coli bacteremia transmitted by fecal microbiota transplant;DeFilipp;N Engl J Med,2019

3. Fecal microbiota for transplantation—safety alert: risk of serious adverse events likely due to transmission of pathogenic organisms;US Food and Drug Administration

4. Fecal microbiota transplantation for dysbiosis—predictable risks;Blaser;N Engl J Med,2019

5. SER-109, an investigational microbiome drug to reduce recurrence after Clostridioides difficile infection: lessons learned from a phase 2 trial;McGovern;Clin Infect Dis,2020

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