Quay was the first UK contracting company to bring live bacteria into a finished product and it is one of the few companies globally able to handle this work on a large scale.
This led Quay to become the first UK company to be granted a licence to provide clinical trials materials for BSL Class II live microbes to be administered in non-sterile forms to target the digestive, urogenital, otorhinologic and pulmonary pathways.
The newness of this process also meant Quay worked closely with the MHRA to define the licence category and to approve the systems and levels of containment required to satisfy the regulators.
“This is a very exciting development, and there many initiatives in their early stages,” said Maireadh Pedersen, CEO at Quay.
“Our MHRA licence and successful FDA inspection mean we are now ideally placed to help companies prepare and implement a formulation and clinical trials strategy to provide the appropriate dosing solution for these live biotherapeutics. We can therefore help to bring these treatments rapidly and effectively to first in man studies and provide the critical process environment required to ensure the best chance of clinical outcome,” she said.
With the growth in understanding of how the human microbiome affects disease states, immune responses and even drug metabolism in the body, the potential for live microbes to treat a huge variety of gastrointestinal as well as many other disorders via the non-sterile delivery route is immense.
According to Quay, its breadth of expertise in formulation development across many delivery routes, in combination with its understanding of isolation and containment techniques, means it is perfectly positioned to support businesses developing products utilising live bacteria either to treat or elicit other responses within the body.
Quay has provided product for UK and US companies for clinical trials and is currently working on formulation development and clinical trials supply for a number of other US and European companies.
As well as the investment in other specialist isolation technology to control the environment around the bacteria during processing, Quay is in the final stages of completing the qualification of new GMP production suites for larger scale projects.
