From Stool Donation to FMT Preparation: The Logistics of FMT Manufacturing

Fecal microbiota transplantation (FMT) preparations comprise minimally processed stool that retain a broad fraction of the stool donor’s complete microbiome. In clinical trials and real-world settings, FMT has been shown to treat approximately 80% of antibiotic-resistant C. difficile infections and is the standard of treatment for recurrent C. difficile. This paper, using OpenBiome as an example, reviews important considerations for manufacturing FMT preparations including safety and operational measures. Note: Considerations for donor screening are covered separately in a white paper titled “Clinical Considerations for Donor Selection”