Recombinant live biotherapeutics and synthetic biology: Recent advancement and perspective

Prog Mol Biol Transl Sci. 2026:220:65-86. doi: 10.1016/bs.pmbts.2026.01.004. Epub 2026 Jan 21.

Abstract

The human gut microbiota is complex environment of diverse microbes that constitutes a key factor in health, immune responses, balance between the microbial community, metabolism, and prevention of diseases. Live biotherapeutic products (LBPs) are engineered live microorganisms that are being used to treat different diseases. LBPs have emerged as promising therapy for the treatment of different human diseases, which include metabolic disorders, pathogenic infections, inflammatory bowel disease (IBD), and cancer overcoming the traditional use of probiotics. Current progress in synthetic biology and genetic engineering have enabled the precise modifications of microbes, which leads to the targeted modulation of interactions with host-microbiome, disease pathways, and immune responses. This chapter highlights the principle of LBPs, interaction between host and its immune response, delivery mechanism and strategy of colonization and applications of LBPs. Key role of synthetic biology in development of LBPs is also discussed. The application of LBPs into clinical use leads to the introduction of safety and regulatory considerations. The delivery of LBPs can be regulated by introducing the biocontainment strategy into the microbes. Looking forward, synergistic engineering methods, personalized microbial consortia, computational biology tools for design of genetic circuits may serve as the foundation for further improvement in the LBPs with the future potential.

Keywords: Engineered microorganisms; Gut microbiota; Inflammatory bowel disease; Live biotherapeutic products; Probiotics; Synthetic biology.

Publication types

  • Review

MeSH terms

  • Animals
  • Biological Products* / therapeutic use
  • Biological Therapy*
  • Humans
  • Synthetic Biology*

Substances

  • Biological Products