Drugging the microbiome and bacterial live biotherapeutic consortium production

• Published in: Current opinion in biotechnology Vol. 78; p. 102801
• Main Authors: McChalicher, Christopher WJ, Auniņš, John G
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.2022
• Subjects: Bacteria; Humans; Microbiota; Quality Control
• ISSN: 0958-1669; 1879-0429
• DOI: 10.1016/j.copbio.2022.102801

Research leading to characterization, quantification, and functional attribution of the microbes throughout the human body has led to many drug-development programs. These programs aim to manipulate a patient’s microbiome through the addition of new strains or functions, the subtraction of deleterious microbes, or the rebalancing of the existing population through various drug modalities. Here, we present a general overview of those modalities with a specific focus on bacterial live biotherapeutic products (LBPs). The bacterial LBP modality has unique concerns to ensure product quality, thus, topics related to manufacturing, quality control, and regulation are addressed. [Display omitted] •Microbiomes represent new drug targets for pharmaceutical development.•‘Dysbiosis’ describes poor composition or species balance, contributing to disease.•Live biotherapeutic products (LBPs) are an enriching class of microbiome therapies.•Manufacture leverages vaccine experience but must be adapted for commensal strains.•Variety of LBPs require per-product assessment of required quality elements.