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

J Infect Dis. 2021 Jun 16;223(12 Suppl 2):S283-S289. doi: 10.1093/infdis/jiaa779.

Abstract

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

Keywords: gut microbiome; infection; live biotherapeutic product (LBP); multi-drug resistant organisms (MDRO).

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / pharmacology
  • Anti-Bacterial Agents / therapeutic use
  • Bacterial Infections / prevention & control
  • Bacterial Infections / therapy*
  • Biological Products / pharmacology
  • Biological Products / therapeutic use*
  • Drug Development*
  • Drug Resistance, Multiple, Bacterial / drug effects
  • Fecal Microbiota Transplantation
  • Gastrointestinal Microbiome / drug effects
  • Humans

Substances

  • Anti-Bacterial Agents
  • Biological Products