Live Biotherapeutics

What constitutes being a human? It would appear that it means being predominantly made up of bacterial cells. It is estimated that only one tenth of our cells are actually human.

The community of micro-organisms we carried around with us are referred to as our microbiome. Research has shown that our microbiome directly influences our immune system and using this knowledge researchers are now looking at how, by influencing our immune system, we can address various diseases.

Many of the innovative, microbiome therapeutic companies working in this space are looking to use the direct application of specific individual bacterial strains, or groups of strains (consortia), to directly impact the localised microbiome of an individual. This can be within the gut, on the skin or anywhere else in the body.

Quay consulted nearly five years ago with the MHRA to allow us to bring these innovative new therapies in to our multi product, manufacturing facility with a specific focus on oral and topical delivery. The experience that Quay has developed in the formulation and clinical manufacture of microbiome based medicines, or live biotherapeutics*, cannot be matched by any other CDMO. Quay is one of very few companies globally who can support the manufacture of live biotherapeutics in its facility.

*Live biotherapeutics is the term given by the FDA to a biological product, that contains a living organism, is applicable to the prevention, treatment or cure of a disease or condition of human beings and is not a vaccine.