Quay Pharma has established specialist GMP suites at its facility in Deeside, Flintshire as part of an investment in their live biotherapeutics services.

Quay is the first UK contracting company to bring live bacteria into a finished product, and it is one of the few companies globally with the ability to handle this work on a large scale. Quay has also already become the first UK company to be granted a license 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.  

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.

“This is a very exciting development, and there many initiatives in their early stages,” comments Quay chief executive officer Maireadh Pedersen.  “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 in order 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.”