Panel: fecal-derived therapeutics now FDA-approved; measuring potency and safety is complex

Scott Jackson (The Nest) walked the panel through how efforts to commercialize microbiome therapies have matured and why fecal-derived live biotherapeutic products raise unique analytical questions for regulators and manufacturers. "There are FDA-approved microbiome-targeted therapeutics...they are fecal-derived products," Jackson said, emphasizing that manufacturing, purity, identity, viability, and potency assays are central challenges for ensuring safety and reproducibility.

Jackson noted that fecal microbiome transplants have demonstrated efficacy beyond C. difficile — including reductions in antimicrobial-resistant bacterial load pre-surgery in some published studies — and that standardized reference materials and validated measurement techniques will be essential as companies scale and as biosimilars emerge.