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

Christopher McChalicher; Ahmad Abdulaziz; S Steve Zhou; Mary-Jane Lombardo; Brooke Hasson; John G Auniņš; Barbara H McGovern; David S Ege

doi:10.1093/ofid/ofac448

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

Open Forum Infect Dis. 2022 Sep 2;9(9):ofac448. doi: 10.1093/ofid/ofac448. eCollection 2022 Sep.

Authors

Christopher McChalicher¹, Ahmad Abdulaziz¹, S Steve Zhou², Mary-Jane Lombardo¹, Brooke Hasson¹, John G Auniņš¹, Barbara H McGovern¹, David S Ege¹

Affiliations

¹ Seres Therapeutics, Cambridge, Massachusetts, USA.
² Microbac Laboratories, Inc, Sterling, Virginia, USA.

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.

Keywords: Clostridioides difficile infection; microbiome; microbiome therapeutic.