Recent advances in synthetic biology and microbiome engineering have offered a unique opportunity to design biotherapeutics for the treatment of human diseases by modifying microorganisms with disease-specific pathways.
The gastrointestinal (GI) tract is inhabited by communities of microorganisms composed of a diverse consortium of bacteria, archaea, fungi, protozoa, and viruses. Each person harbors a unique gut microbiome profile involved in the maintenance of homeostatic functions (1). Our increased understanding of the microbiota composition and microbiota metabolite profile, as well as their relation to disease susceptibility in the host, has created unique opportunities to develop therapies for the treatment of multiple debilitating diseases.
The concept of altering the GI microbiome to improve health is now well established, and microbiome-based therapeutics — including fecal microbiota transplantation (FMT), microbial consortia, or single-strain probiotics — have been successfully used to treat multiple ailments ranging from Clostridioides difficile (C. diff.) infection to inflammatory bowel disease (2). These approaches offer the potential of reintroducing essential species with critical homeostatic functions, but also present challenges as the broad biological effects of the reintroduced organisms are highly dependent on the existing microbiota composition and require challenging manufacturing processes that are difficult to scale up (3).
Recent advances in synthetic biology and microbial engineering have opened up the possibility of modifying organisms to introduce specific functions, offering a different and novel orally administered, non-systemically absorbed option with a more targeted mechanistic approach that is relatively microbiome-independent.
This article discusses current strategies developed for the engineering of bacteria and illustrates the progress made toward advancing engineered probiotics to deliver therapeutic functions within the GI tract for the treatment of rare metabolic diseases...\
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