Microbiota-directed biotherapeutics: considerations for quality and functional assessment

ABSTRACT

Mounting evidence points to causative or correlative roles of gut microbiome in the development of a myriad of diseases ranging from gastrointestinal diseases, metabolic diseases to neurological disorders and cancers. Consequently, efforts have been made to develop and apply therapeutics targeting the human microbiome, in particular the gut microbiota, for treating diseases and maintaining wellness. Here we summarize the current development of gut microbiota-directed therapeutics with a focus on novel biotherapeutics, elaborate the need of advanced -omics approaches for evaluating the microbiota-type biotherapeutics, and discuss the clinical and regulatory challenges. We also discuss the development and potential application of ex vivo microbiome assays and in vitro intestinal cellular models in this context. Altogether, this review aims to provide a broad view of promises and challenges of the emerging field of microbiome-directed human healthcare.

KEYWORDS:

• Biotherapeutics
• metaproteomics
• microbiome assay
• microbiota
• multi-omics

Acknowledgments

This work was supported by the Government of Canada through Health Canada. The opinions expressed in this publication are those of the authors and not represent the views of Health Canada. We gratefully acknowledge Dr. Simon Sauvé, Dr. Michael Rosu-Myles, Dr. Huixin Lu, Dr. Eric Deneault, Dr. Deepak Sharma, and Dr. Allison Sherratt from Health Canada for critical comments and edits on the manuscript.

Disclosure statement

D.F. co-founded MedBiome, a clinical microbiomics company. All other authors declare no potential conflicts of interest.

Additional information

Funding

The work was supported by Genome Canada and Health Canada.