Pharmaceutical contract developer and manufacturer, Quay Pharma, has further expanded its range of services following MHRA approval for the manufacture of commercial batches of drugs at its two production sites in Deeside, North Wales, and Bromborough, near Liverpool.
This extension to its manufacturing capabilities will allow Quay to support its clients through all stages of drug development and clinical supply as well as pre-qualification batches to support Marketing Authorization applications and initial manufacture of commercial product.
The ability to manufacture commercial batches reinforces Quay’s focus on supporting the requirements of orphan drug companies for whom continuity of manufacturing for small quantities of product is desirable.
All Quay’s manufacturing areas are fully compliant with GMP (Good Manufacturing Practice), as the company also holds a licence for the manufacture and testing of Investigational Medicinal Products (IMPs), including medical devices, and has successfully been doing this for the last 14 years.
In addition, Quay is one of the few companies licenced by the MHRA to carry out Specials Manufacture – the production of unlicensed medical products developed to meet the particular clinical requirements of individual patients whose needs cannot be met by licensed medicines.
“The attainment of our Commercial Licence, in combination with our Specials Licence, is another important step in Quay’s growth and development and demonstrates our ongoing commitment to support our key customers who develop drugs for rare and neglected diseases,” comments CEO Maireadh Pedersen.
“We now have the added flexibility to be able to help our clients take their drugs from successful trial to initial commercial manufacture in one seamless process,” she added.