fig2

Figure 2. Schematic representation of steps required for approval of 2nd Generation microbiome-based therapies, also known as biological drugs. Both LBPs and MBPs therapies must be tested for safety in preclinical assays, produced under Good Manufacturing Practices, and tested in human clinical trials for safety and efficacy before being approved as biological drugs. LBPs: Live biotherapeutic products; MBPs: microbiota-based products.