Surrey, UK, 28th June, 2010 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that it has received an award from PharmInd for a Process Analytical Technology (PAT) research project to assure the quality of a pharmaceutical product by online measurement of critical process parameters.
PAT tools are a regulatory requirement covered under the International Conference on Harmonisation (ICH Q8) and a requirement of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NextPharma’s focus as part of the research project was the online measurement of moisture determination in the granulation processes for solid dosage forms. Measurements of moisture content are required to optimise the time for the granulation process; non-optimisation can lead to variations in product quality.
The work involved collaboration between NextPharma, the University of Düsseldorf (Institute for Pharmaceutical Technology), the granulation equipment manufacturer Glatt and the sensor provider Advanced Microwaves Systems.
As part of this work a microwave sensor was installed in a fluid bed granulator to measure granule humidity through simultaneously measuring water and density without being in contact with the product itself. As a result of this work online measurement of product humidity can be monitored over the whole granulation process and enables the accurate determination of the granulation process end-point as well as any deviation during the manufacturing process, improving manufacturing yields and reducing variability.
The project was published in the journal “Pharmind” (www.pharmind.de) and was also granted the second prize for the year’s best article.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services (PDS) commented: “We are very excited to have been part of this collaborative piece of research work and delighted to work alongside the University of Düsseldorf, Glatt and Advanced Microwaves Systems in producing a very positive outcome through enhancement to granulation manufacturing quality, as well as being recognised by PharmInd for this award”.
Bill Wedlake, Chief Executive Officer of NextPharma added “At NextPharma we believe that scientific innovation is central to cost effective manufacturing of pharmaceutical products. Given the growth of outsourcing within the pharmaceutical and biotechnology sectors we are aware of the importance that organisations like NextPharma play in providing scientific innovation and of the increasing reliance on external partners like NextPharma to help to deliver this very important work”.
NextPharma PDS operates globally with seven centers of excellence in Europe and North America. PDS services include preformulation studies, formulation development, design, development and optimization of lyophilization cycles, manufacturing for clinical trial materials, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines as well as regulatory support and product dossier development and registration.
Our expanded sterile business includes sterile product development and manufacturing capabilities in San Diego, California and Braine-l’Alleud, Belgium where we are able to support non-clinical through clinical development of sterile products including biologics and cytotoxics. In addition, our San Diego facility is ISO 13485:2003 certified for medical devices and manufactures medical devices with batch sizes spanning the needs of research and development through to commercial quantities of product.
Our world class PDS team provides customers with the confidence and knowledge that their products will be produced to meet their exact requirements. Customer satisfaction is of key importance to NextPharma: each customer receives a dedicated project manager responsible for managing the development project within NextPharma and ensuring the highest level of customer service. As products transition from development to commercial scale, we are able to provide a seamless process from non clinical product formulation to commercial scale manufacturing, either within NextPharma, or if the customer requires to another company of their choice.
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.
Chief Executive Officer
NextPharma Technologies Holding Limited
Tel +44 (0) 1483 479 121
Notes to Editors:
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
We offer a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing. We are a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally we have significant expertise in paediatric drug formulation, development and manufacture. NextPharma offers ‘one-stop’ logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP/GDP regulations.
We operate globally with seven product development centres, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
We have 1,200 employees dedicated to serving over 200 customers world wide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies.
We have a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of our sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.
About University of Düsseldorf
The Heinrich Heine University of Dusseldorf located in Dusseldorf, Germany, has over 16,000 enrolled students and is named after the German poet and political thinker Heinrich Heine who was born in Düsseldorf in 1797. It became a fully-fledged university in 1965 and currently comprises faculties of law, medicine, philosophy, mathematics, natural sciences and economics.
The Glatt Group has been supplying solid dosage technology, equipment, integrated systems and processing expertise to the global pharmaceutical industry for the past fifty years along with the highest level of support and commitment possible. Today, Glatt Pharmaceutical Services uses this extensive experience and knowledge to provide solutions to its clients and partners from the initial concepts in product and formulation development through process scale-up to commercial manufacturing of solid dosage products.
About Advanced Microwaves Systems (AMS)
AMS was founded in 2001 to research, develop and manufacture moisture measurement systems. It is the joint enterprise of Claas and Jörn Döscher with Prof. Dr.-Ing. Reinhard Knöchel, Chairman of the Institute of High Frequency at the University of Kiel, who is also one of the leading experts in microwave measurement technology.
PharmInd is a production and distribution pharmaceutical publication. PharmInd acts as a pharmaceutical industry forum covering all themes of health care and public health affairs affecting the production and distribution markets across Germany, Austria and Switzerland.
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Last updated on: 27/08/2010