Surrey, UK, 2nd September 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 expanded its core capabilities through the extension of its microbiology facilities at its site in Göttingen, Germany.
The expansion of the microbiology department includes the addition of three new state-of-the-art laboratories equipped with modern air ventilation, laminar-flow benches and temperature-controlled incubators linked to a computerized monitoring system that helps to ensure a constant temperature throughout the incubation period. The microbiology department meets the highest GMP standards, is EU and FDA compliant and is a significant addition to the Göttingen site.
The new laboratories will be used to develop and validate microbiological methods as well as to test non-sterile pharmaceutical products, medical devices and cosmetics for microbial purity and preservative efficiency. Additionally, the new laboratories can work sequentially to process samples enabling a high throughput of testing. Overall, the microbiology department in Göttingen has the capacity to test some 40,000 samples per year. Microbiological testing of sterile products will continue to be undertaken at NextPharma’s Belgium facility.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services commented: “We are delighted to expand our microbiology department in Göttingen which will enable us to grow our Product Development Services offering in this field of expertise. We look forward to working with new and existing customers in the pharmaceutical, medical device and cosmetics markets.”
NextPharma Product Development Services (PDS) operates globally with seven centers of excellence in Europe and North America. PDS services include pre-formulation studies, formulation development, including New Chemical Entities (NCEs), Peptides and New Biological Entities (NBEs), design, development and optimization of lyophilization cycles, manufacturing of investigational medicinal products, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines, scale-up services and regulatory support, including product dossier development and registration.
NextPharma Göttingen has many years of experience in the manufacture and packaging of solid dosage forms. In recent years, significant investments have been made in the manufacturing and packaging of conventional solid dosage forms, including the completion of a state-of-the-art tablet bottle filling line in July 2010. In addition to tablets and hard gelatin capsules NextPharma Göttingen manufactures and packages effervescent tablets and sachets and provides Alu-Alu blister packaging. Additionally, NextPharma Göttingen undertakes formulation development and analytical testing of solid forms, microbiological testing, manufacture of investigational medicinal products and clinical trial labeling and kitting. .
NextPharma also has a separately housed cephalosporins plant in Göttingen which accommodates the production of various cephalosporin dosage forms while NextPharma Berlin has separate dedicated production facilities to produce penicillins and amoxicillin-clavulanic acid. Both production plants have their own separate warehouses and also offer alu alu blistering.
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
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 and manufacturing of investigational medicinal products, 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 capabilities include 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.