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

Christopher McChalicherAhmad AbdulazizS Steve ZhouMary-Jane LombardoBrooke HassonJohn G AuniņšBarbara H McGovernDavid S Ege
Published in: Open forum infectious diseases (2022)
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.
Keyphrases
  • sars cov
  • respiratory syndrome coronavirus
  • clostridium difficile
  • coronavirus disease
  • phase ii
  • randomized controlled trial
  • study protocol
  • open label