Biopharma companies are currently developing the next new modality of drugs: live bacteria. These “bugs-as-drugs” (categorized as “Live Biotherapeutic Products” (LBPs) by the FDA) are demonstrating promising clinical efficacy and could change the paradigm for treating a wide range of diseases and health conditions. The quality of these manufactured LBPs must meet extremely high standards as per FDA regulation. New, validated analytical methods for demonstrating the identity, purity, potency and stability must be established.
MicrobiomePost discussed these topics with Morten Isaksen (BIO-ME) during the Microbiome Connect: USA 2022 congress, last November in Boston.