The facility has also undergone a successful re-inspection by the MHRA (the UK Medicines and Healthcare products Regulatory Agency), confirming that the company is fully compliant with good manufacturing practices (GMP).
The new equipment includes an ion chromatography system, which has been added to Quay's analytical development instrumentation portfolio to support two new projects requiring this specialist capability.
The first of the projects concerned is for a French biopharmaceutical company, which is seeking to develop products for severe neurological disorders. The instrumentation will be used with pulsed amperometry electrochemical detection to monitor extremely low levels of sugars in a combination drug product.
The second project, for a new UK pharmaceutical company, involves measurement of a cationic drug (API) and its degradation products by conductivity detection.
In addition, the Formulation Development department, which specialises in the development of solid dosages, creams, liquids and gels, has been expanded to include a new pilot facility alongside the laboratory.
This pilot lab will offer the capability for early phase work in standard techniques such as tabletting, coating and capsule filling, as well as more complex processes such as extrusion spheronisation and semi-solid and liquid filling and banding of capsules. It will assist in the scale-up of production prior to full manufacture as well as providing proof of concept studies and samples for pharmacokinetic (PK) studies.
As well as the investment in new equipment, Quay is also planning to introduce new GMP manufacturing suites, with work on these expected to start in the autumn.
‘The move to the new premises has effectively quadrupled the available space for these important departments and will allow us to provide a greatly enhanced range of services to both existing and new customers,’ said Quay Pharma’s chief executive Mike Rubinstein.
‘At the same time, we are delighted that our commitment to the highest quality and best practice has been confirmed by our successful MHRA inspection.’
