The human body includes tens of trillions of cells, but not all of them are human! This article focuses on the at-least 30 trillion non-human cells that we each carry with us – our microbiome. These non-human cells include bacterial and fungal species, together with viruses, and can be found throughout our bodies, including the skin, respiratory tract, and gut.
There are many hundreds of species of non-human cell present in varying combinations in different sites throughout the body, with the result that even within one individual there are many incredibly diverse microbiomes. There is also considerable variation between individuals, with the microbiome being at least as unique as a fingerprint. However, unlike fingerprints, microbiomes are dynamic and change with age, as well as in response to environmental factors such as lifestyle choices and antibiotic use. It is becoming increasingly clear that our microbiomes play a key role in keeping us healthy, contributing to areas as diverse as digestion, blood pressure, mental health, sleep, obesity, and even athletic performance.
It is therefore unsurprising that there is growing commercial interest in the microbiome and that the microbiome is itself becoming an important sector in the biotechnology industry. Last year, 2020, saw the publication of results from the first positive phase 3 clinical trial of a live biotherapeutic product targeting the microbiome, showing that treatment with healthy bacteria can reduce recurrent gastrointestinal infection. There are several other potential microbiome therapies following closely behind for treating a variety of different diseases, so it seems likely that approval of the first microbiome therapy is not far away. We may be on the threshold of an entirely new class of therapeutic!
Of course, the field is not without its challenges, not least because bacterial products targeting the microbiome are highly complex compared to traditional therapeutics. Such products are often a cocktail of various bacteria, with efficacy dependent upon interactions between the different species. It is also true that the fundamental science surrounding microbiomes and microbiome products is not yet well understood. Additional challenges arise from the complex data-handling that is needed to understand microbial communities, potential problems with manufacture and distribution of a living product, and the appropriate regulatory framework to ensure safety and reproducibility. In the world of intellectual property, there are also specialist considerations including the patent eligibility of naturally occurring elements in the USA, how to go about defining commercially useful protection, and how to assess potential infringement risk. Commercialisation of inventions relating to the microbiome is likely to require a more tailored and flexible approach, as best practice in various areas continues to develop.
Of course, microbiome inventions are not only concerned with human health. Soil and plant microbiomes are important to agriculture and plant health, and there are many potential uses in industry for commensal bacterial found in our microbiomes, relating to everything from food manufacture to complex synthetic biology. The microbiome has the potential to contribute solutions to some of the big issues of the day, including global food security and climate change.
For those willing and able to navigate the challenges that will inevitably arise in this new and fast-moving field, there is truly a microbiome of opportunity.
Originally published 14 January 2021
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