Seminar: "Biomanufacturing and Quality Control for the Next New Therapeutic Modality: Live Microbes"
Over the last 20 years, the human microbiome has been implicated in myriad health and disease conditions including mental illness, cancer, and metabolic disorders. These discoveries have spawned a new industry sector where biopharma and biotech companies are racing to develop the next generation of therapeutics and diagnostics that target the human microbiome. Designated by FDA-CBER as Live Biotherapeutic Products (LBPs), these new therapeutic modalities consist of complex consortia of microbial species that are designed to restore healthy/normal microbiome function. Research and development includes the utilization of multi-omic technologies to measure the structure and function of these complex microbial consortia. Additionally, the biomanufacturing of LBPs is mired by the lack of validated analytical methods that are necessary to demonstrate the various quality attributes of these extremely complex therapeutic modalities. This presentation will focus on the current state of the industry and the ongoing efforts at NIST to develop standards for microbiome measurements.