The expanded capabilities will allow the firm to support its clients through all stages of drug development and clinical supply
Quay Pharma has expanded its service offering following MHRA approval for the manufacture of commercial batches of drugs at its two production sites in Deeside, North Wales, and Bromborough, near Liverpool.
The UK-based pharmaceutical contract developer and manufacturer says the extension to its capabilities will allow the firm to support its clients through all stages of drug development and clinical supply, as well as pre-qualification batches to support Marketing Authorisation 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 of Quay’s manufacturing areas are 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.
Quay also has an MHRA licence to carry out Specials Manufacture.
'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 on-going commitment to support our key customers who develop drugs for rare and neglected diseases,' said 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.'