Microbiota-directed biotherapeutics: considerations for quality and functional assessment

Area of Science:

• Microbiome research
• Therapeutic development
• Human health

Background:

• The gut microbiome plays a critical role in numerous diseases, including gastrointestinal disorders, metabolic diseases, neurological conditions, and cancers.
• This understanding has spurred the development of therapeutics targeting the human microbiome, particularly the gut microbiota, for disease treatment and health maintenance.

Approach:

• This review summarizes the current progress in gut microbiota-directed therapeutics, emphasizing novel biotherapeutics.
• It highlights the necessity of advanced multi-omics approaches for evaluating these microbiota-based therapies.
• The review also discusses the utility of ex vivo microbiome assays and in vitro intestinal cellular models.

Key Points:

• Focus on novel biotherapeutics for microbiome-directed therapies.
• Importance of advanced -omics approaches for evaluating therapeutic efficacy.
• Exploration of ex vivo and in vitro models for preclinical assessment.

Conclusions:

• The field of microbiome-directed therapeutics holds significant promise for human healthcare.
• Challenges in clinical translation and regulatory pathways need to be addressed.
• Integration of advanced -omics and in vitro/ex vivo models is crucial for future development.