Opportunities and Challenges in Development of Live Biotherapeutic Products to Fight Infections

Abstract Treatment of bacterial infections with broad-spectrum antibiotics is a strategy severely limited by the decreased ability perturbed resident microbiota to control expansion antibiotic-resistant pathogens. Live biotherapeutic products (LBPs) could provide an alternative in infection restoring gut colonization resistance and controlling resistant strains, important therapeutic need not being addressed existing anti-infective drug modalities. We review opportunities challenges developing LBPs for multidrug-resistant organisms control, focus on commercial fecal transplantation-like defined consortia, spanning considerations related availability models rational candidate selection dose regimen selection, good manufacturing practice, intellectual property, viability.