Manufacturing Process of SER-109, a Purified Investigational Microbiome Therapeutic, Reduces Risk of Coronavirus Transmission From Donor Stool
Christopher McChalicher, Ahmad A. Abdul-Aziz, S Steve Zhou, Mary-Jane Lombardo, Brooke Hasson, John Auniņš, Barbara McGovern, David S. Ege
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.
Topics & Concepts
MedicineCoronavirus disease 2019 (COVID-19)Transmission (telecommunications)Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Microbiome2019-20 coronavirus outbreakCoronavirusManufacturing processVirologyMicrobiologyBioinformaticsInternal medicineBiologyMaterials scienceEngineeringComposite materialInfectious disease (medical specialty)OutbreakDiseaseElectrical engineeringSARS-CoV-2 and COVID-19 ResearchClostridium difficile and Clostridium perfringens researchGut microbiota and health