Live Biotherapeutic Products (LBPs) represent a promising and rapidly advancing class of therapeutics that harness live microorganisms to prevent, treat, or manage a wide spectrum of health disorders. Distinct from traditional probiotics, prebiotics, and synbiotics, LBPs are rigorously developed and regulated as medicinal products with defined compositions, mechanisms of action, and clinical indications. Looking ahead, the therapeutic potential of LBPs is expanding well beyond gastrointestinal disorders, with promising applications in areas such as metabolic, neurological, and immune-mediated diseases. Their integration into precision medicine frameworks holds significant promise for shaping the future of public health. This chapter provides an overview of currently available LBPs, their mode of actions, clinical applications, and the regulatory frameworks that distinguish them from other microbial-based therapies. It also highlights the growing diversity of LBPs from single-strain products to engineered microbial communities and natural formulations, emphasizing their unique clinical value and increasingly advanced mechanisms of action. The clinical development of LBPs faces key challenges, including strain selection, complex manufacturing, viability issue and safety concerns in vulnerable populations with comorbidities, and navigating evolving regulatory frameworks. Advances in synthetic biology, CRISPR genome editing, and multi-omics are transforming LBP design, enabling more precise and personalized therapies. The evolving LBP landscape with key industry players, clinical trials, and strategic partnerships offers critical insights into the innovation and commercialization driving this dynamic field.
Keywords: Biotherapeutics; FMT; GMO; Gastrointestinal tract; Lactobacillus; Microbiome; Probiotics; Synbiotics.
Copyright © 2026. Published by Elsevier Inc.