End-to-end donor screening and manufacturing controls: complementary quality-based strategies to minimize patient risk for donor-derived microbiome therapeutics

Advances in microbiome therapeutics have been motivated by a deeper understanding of the role that the gastrointestinal microbiome plays in human health and disease. The FDA approval of two stool-derived live biotherapeutic products (LBPs), REBYOTA® 150 mL enema (fecal microbiota, live-jslm; formerl...

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Bibliographic Details

Published in:	Gut Microbes
Main Authors:	Jason Goldsmith, Sarah Tomkovich, John G. Auniņš, Barbara H. McGovern, Jennifer C. Mahoney, Brooke R. Hasson, Christopher W J McChalicher, David S. Ege
Format:	Article
Language:	English
Published:	Taylor & Francis Group 2024-12-01
Subjects:	Microbiome microbiome therapeutics live biotherapeutic products stool donors fecal transplant
Online Access:	https://www.tandfonline.com/doi/10.1080/19490976.2024.2402550