First time that Japanese company has outsourced clinical trials manufacture to UK
Quay Pharma, a UK provider of contract pharmaceutical r&d and clinical trials manufacturing, has won a contract with a Japanese pharmaceutical company to handle the clinical trial drug manufacture of two NCEs for UK trials. The contract was won in conjunction with Quay’s Japanese representative, InterPharm Express.
This is the first time that the Japanese company, which focuses on developing treatments for diseases in the elderly, has outsourced clinical trials manufacture to a European company.
Quay says it was chosen because it could respond quickly and meet tight deadlines and has a strong partnership with InterPharm Express, which will ensure a high level of support in Japan.
Quay Pharma’s services include formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging from a new £2.7m purpose-built facility in Deeside, North Wales.
As part of the implementation of the new projects, Quay has purchased additional manufacturing equipment including a Quadro Comil cone mill and a specially commissioned, bespoke V shell blender. Matching the equipment used by the client in Japan has ensured that the transfer of the project from Japan to the UK has gone smoothly while also allowing the flexibility of scale-up for future manufacturing needs.
‘We are extremely proud to have been selected for these prestigious projects,’ said Quay Pharma’s chief executive Mike Rubinstein.
‘The Japanese pharmaceutical industry is renowned for its rigorous quality requirements, and our appointment therefore reflects and underlines the high standards that characterise all our work.’