As part of the move to its purpose-designed facility in Deeside, North Wales – which was officially opened by the Deputy First Minister of Wales last year - pharmaceutical outsourcing specialist Quay Pharma has invested in a variety of new equipment to further enhance its range of support services for clients.
The new site has also now undergone a successful re-inspection by the MHRA (the UK Medicines and Healthcare products Regulatory Agency), confirming that Quay is fully compliant with good manufacturing practices (GMP).
The new equipment includes a state-of-the-art ion chromatography system which has been added to Quay's portfolio of analytical development instrumentation to support two new projects requiring specialist analytical capability. For most developments, drug substances are assayed using conventional high performance liquid chromatography with ultraviolet (UV) detection but the compounds involved in these latest projects are transparent to UV light making this standard technique impossible.
The first of the projects concerned is for a leading French biopharmaceutical company, which is seeking to develop products for severe neurological disorders. The system 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. The pilot lab will offer the capability for early phase work in standard techniques such as tableting, 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 commence 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," comments 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."
Pharmaceutical outsourcing specialist Quay Pharma is sponsoring and exhibiting at a series of seminar programmes in association with the NIHR Medicines for Children Research Network (MCRN) which highlight the latest developments in the creation of medicines for children and adolescents.
The first event, Sharing Best Practice on Widening Participation in Children's Research, took place in Manchester at the beginning of March. A second one day programme, the Trent Local Children's Research Network (TLC-RN) 4th Annual Paediatric Research Meeting, will be held in Nottingham on 4th May.
The keynote address at the Nottingham event will be from Professor Terence Stephenson, President of The Royal College of Paediatrics and Child Health, who will talk about A Decade of Change in Medicines for Children.
In addition, Professor Anne Greenhough, Head of Kings College London School of Medicine and Director of Education and Training at Kings Health Partners, will be presenting the national picture of Non-Medicines Paediatric Research, while there will also be a series of presentations and case studies on MCRN and non-medicines paediatric research.
Quay's involvement in these events is part of the company's ongoing development of medicines that specifically target prevention, diagnosis and treatment in young people.
"It is becoming increasingly clear that reduced doses of proven adult drugs may not always be the most effective way to treat children and adolescents," explains Mike Rubinstein, Chief Executive of Quay Pharma.
"There is a lot of important work currently taking place in paediatric drug research and development and we are delighted to be able to highlight this through our support for these events. This type of work is also an important part of our own operations and is another area of expertise that we can offer to our client base."
Full details of the Nottingham event can be found at www.trent-mcrn.org.uk/viewevent.
As part of its continuing expansion programme, Quay Pharma has appointed Mark Powell as Scientific Manager. Dr Powell has been with Quay for nearly eight years and was previously in charge of the company's Analytical Development Group.
Dr Powell has also been elected Honorary Treasurer for the Analytical Division of the Royal Society of Chemistry (RSC).
In his new role at Quay, Dr Powell will take on wider technical responsibility and seek to further raise the scientific profile of the company. Quay's areas of expertise in solid dosage development cover a broad range of formulation types including lipophilic systems, and are supported by the development of analytical methods for the challenging recovery of API from lipid systems.
Dr Powell has a PhD in Analytical Chemistry and his wide-ranging experience includes work in the water industry, as a consultant and as a senior lecturer at Liverpool John Moores University.
"Mark's in-depth knowledge and skills are invaluable to our client base and in his new role he will help us to consolidate and further develop our reputation and extensive range of specialist services," comments Quay Pharma's Chief Executive Mike Rubinstein. "We are also delighted that his abilities have gained even wider recognition through his work with the RSC."
As Honorary Treasurer of the RSC Analytical Division, Dr Powell will oversee the Analytical Chemistry Trust Fund which helps to support research projects, provides travel grants for overseas students and promotes an annual schools competition. The fund is also now introducing a world scholarship programme, helping researchers in developing countries to spend time and gain experience in the UK.
"I am delighted to be part of a programme that helps to promote all that is good about the chemical industry and encourages the development of skills that are essential to UK industry," comments Mark Powell. "This is something that is also very important to Quay as encouraging the next generation of chemists will be vital to ensure the company's continued success and growth."
Quay Pharma has been appointed by a leading 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.
The appointment is significant because this is the first time that the Japanese company, which has a strong focus on the development of innovative products to treat diseases in the elderly, has outsourced clinical trials manufacture to a European company.
Quay was selected due to its responsiveness and ability to meet the tight timelines specified by the customer as well as its strong partnership with InterPharm Express, which ensured a high level of local support in Japan.
Quay Pharma has established a high quality reputation for its specialist outsourcing services including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging. The company has recently moved to a new purpose-designed 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, made to the exact requirements of the client. Matching the equipment that the client had used in Japan ensured that transfer of the project from Japan to the UK went as smoothly as possible and also allowed the flexibility of scale-up for future manufacturing needs.
“We are extremely proud to have been selected for these prestigious projects,” comments 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 extremely high standards that characterise all our work.”
Pharmaceutical outsourcing specialist Quay Pharma’s new purpose designed laboratories and headquarters have been officially opened by the Deputy First Minister of Wales, Ieuan Wyn Jones.
The £2.7m facility in North Wales, which was supported by a £784,000 Single Investment Funding by the Welsh Assembly Government, has enabled Quay Pharma to bring together its entire range of services – which were previously housed in two separate facilities – under one roof. The company has also installed a variety of new equipment to meet increasing demand for its specialist capabilities which includes formulation development, novel drug delivery design, analytical method development and clinical trial manufacturing and packaging. It is anticipated that around 65 new R&D jobs will be created over the next three years as a result of this investment.
Mr Jones unveiled a plaque to commemorate the opening, and toured the new facility.
“We are proud of Wales’ healthcare and bioscience sector which employs some 15,000 people and is worth £1.3 billion every year,” he commented. “I am therefore especially pleased that we have been able to offer assistance to Quay Pharma to facilitate their expansion programme, and I hope that their imminent R&D funding will be of further assistance.”
Established in 2001 by Professor Mike Rubinstein, Quay Pharma provides formulation, analytical development and clinical trials manufacturing for companies world-wide. Quay has particular expertise in oral dosage form design and development and is a specialist in the formulation of drugs that exhibit poor solubility and bio-availability.
“The opening of our new headquarters marks another significant
milestone in Quay’s short but very successful history,”
said Professor Rubinstein. “We will now be able to offer an enhanced
level of support and bring our expertise and specialisation to an even
wider client base.”
Pharmaceutical outsourcing specialist Quay Pharma is investing in excess of £2.5 million in the move to a new purpose-designed facility and headquarters, allowing the company to greatly increase its development and clinical trial manufacturing capacities.
The new site in North Wales, close to Quay Pharma’s existing premises on the Wirral, brings together the company’s entire range of services – currently housed in two separate facilities - under one roof. The 40,800 sq ft building, which is four times the size of Quay’s existing premises, will feature a variety of state of the art equipment that will enable the company to meet increasing demand for its specialist capabilities including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging.
In particular, the expanded operation will provide the opportunity for the further development of Quay Pharma’s expertise in oral dosage form design and development, especially for new chemical entities that exhibit poor solubility and bio-availability
“Our extensive knowledge and experience can play a crucial role in the critical early stages of drug development and in recent years we have seen increasing demand for our services,” comments Quay Pharma’s Chief Executive Mike Rubinstein.
“By creating this new advanced facility to our specific requirements, we will be able to offer an enhanced level of support to our clients.”
Quay Pharma anticipates moving into the new facility from January 2010. The move will be phased to ensure work on existing client projects is maintained throughout.
The new facility is being part funded by a grant from the Welsh Authority Government.
A desire by pharmaceutical companies to concentrate their resources on marketing products, rather than discovery, development and production will drive global revenues for contract manufacturing and research to nearly $168bn by 2009. Of this, approximately 10% will be aimed at CMC work.
This is the conclusion of a soon-to-be-released report from Business Communications Co, which notes that the current market for contract services into the drug industry was $100bn in 2004 and will grow at an average annual rate of at least 11 per cent over the next five years.
However, R&D and marketing functions of major pharmaceutical companies are suffering from declining ‘productivity’. To date, the industry's main strategic response to this - M&A - has not been fully effective in addressing this dynamic.
Nevertheless, many predict that a 'networked' pharmaceutical model is the answer to the longer-term challenges faced by the industry. According to this business model, major pharmaceutical companies, which currently operate approximately 80% of activities
in-house, will eventually perform only 40% in-house.
The remaining 60% will be conducted externally via a carefully selected, risk-managed portfolio of straight outsourcing arrangements and strategic alliances.
In order to properly service it’s increasingly global customer base, Quay Pharmaceuticals is please to announce the recruitment of Business Development Managers and the establishment of contact facilities in Japan
and the USA.
We are delighted to welcome Sansei Oka, who joins us as Business Development Manager, Japan. Sansei began his career in 1973 in drug development and formulation research with Nippon Roche KK, eventually becoming Business Unit Manager of their Pharmaceutical Division. He subsequently moved to Warner-Lambert KK and joined their global business development team. Until very recently Sansei was global marketing manager for Shionogi Qualicaps KK before joining Quay.
Quay’s Japanese contact details:
302 Nakamura Bldg., 2-7-14 Shibuya, Shibuya-Ku, Tokyo, 150-0002, Japan.
Tel: +81 3 5468 7440, Fax: +81 3 5468 7453, E-mail: oka.iptm@topaz.ocn.ne.jp
Confirmation of Quay Pharma's USA agent and contact details in next issue.
Due to rapid expansion in it’s client base, Quay’s existing facilities at Apex Court have recently been ‘creaking at the seams’. In order to accommodate future growth, the company has now taken on additional premises over the road to house the formulation development, analytical developement and quality assurance teams.
The new facility, totalling 8,000 sq.ft. of high specification office and laboratory accommodation, has also allowed the purchase of a new range of equipment to further expand Quay’s analytical and formulation services. This has begun with an LAF cabinet for non-sterile production of PK samples and additional HPLC diode array systems. New equipment will continue to be added until the end of the year.
As part of our expansion into the Hawkshead Road facility, we are pleased to announce and welcome to the team:
Sadaf Anwar PhD - Formulation Scientist
Sadaf completed her PhD ‘Tablet disintegration in complex media’ at Manchester University. This was a collaborative project with AstraZeneca.
The research found that the choice of disintegration media greatly influences disintegration time, due to the properties of the selected media.
Prior to this Sadaf studied Pharmaceutical and Chemical Sciences at Liverpool John Moores University.
Marc Owen - Formulation Scientist
Marc studied M.Chem. at University of Leicester from1997 to 2001.
Marc has previously worked for well known pharmaceutical and large biotechnology companies.
He has experience of synthetic, medicinal and polymer chemistry, pharmaceutical formulation, and laboratory to manufacture scale-up.