Consistent and Reproducible Production of a Microbiota-based Drug for Recurrent C. difficile Infection: Application of a Novel Diagnostic for Dysbiosis

Courtney Jones, BS, Rebiotix Inc., Roseville, MN USA

Summary

Rebiotix has developed a standardized, quality controlled microbiota therapy to treat recurrent Clostridium difficile infection (CDI). This product, RBX2660, is a broad spectrum community of microbes derived from raw material provided by healthy donors. RBX2660 has been repeatedly studied against well-known analytical methods to show preservation of bacteria throughout the manufacturing process. In order to explore new technologies that may be useful in future clinical studies, Rebiotix partnered with Genetic Analysis (Oslo, Norway) to test the well-characterized RBX2660 samples against the newly developed diagnostic tool, GA-map™ Dysbiosis Test.