Quay lands trial manufacturing deal with Japanese pharma

16-Aug-2010 - Last updated on 17-Aug-2010 at 09:43 GMT

A Japanese pharmaceutical company has contracted UK-based Quay Pharma to make trial stocks of two NCEs used to treat genitourinary disorders. One of the products will be entering the first phase of its clinical studies in Europe, while the second is progressing to Phase II.

The appointment renders Quay Pharma the first European company to have been outsourced clinical trials manufacture by the unnamed Japanese company, who have a strong influence in developing products used to help treat diseases in the elderly.

The UK company, now located in North Wales after relocating from the Wirral to a £2.7m ($4.2m) purpose-designed facility in Deeside, will complete the process transfer and scale-up of two wet granulated, film coated, immediate release drugs, in addition to validating all analytical methods to support release of the products for trials.

With the intention of increasing future manufacturing of the two new products, and in order to satisfy the demands of their Japanese clients to maintain a smooth transfer of the project, Quay Pharma have supplemented their manufacturing equipment with a new Quadro Comil cone mill and a bespoke V shell blender.

“We had to go through a thorough screening process in order to win the business,” said Bob Bushby, a spokesman for the company, who told Outsourcing-pharma: “We had to guarantee that we were able to manufacture their product to very exact requirements and use particular equipment to match the original process used in Japan.”

Quay Pharma was considered the strongest candidate for the appointment, thus securing the contract, due to its ability to complete projects within tight timelines, and because of its partnership with Japanese representative, InterPharm Express who heavily contributed to gathering local support in Japan for the company.

Bushby explained how Quay will be working in conjunction with the Japanese company to develop and manufacture the two NCEs by “forming a partnership with the project management team in Japan and joining weekly telephone conferences with the team to progress the project. The key members of the Japanese team will then come over to assist with the process transfer and scale up.”

Mike Rubinstein, Quay Pharma’s Chief Executive said: “We are extremely proud to have been selected for these prestigious projects.

“The Japanese pharmaceutical industry is renowned for its rigorous quality requirements, and our appointment therefore reflects and underlines the extremely high standards that characterise all our work.”