NextPharma Technologies Announces First GMP Manufacture at its Sterile Product Development Center in Belgium
Surrey, UK, 1st April 2009
Surrey, UK, 1st April, 2009 - NextPharma Technologies, a leading provider of pharmaceutical product development, contract manufacturing, cold chain and distribution outsourcing services, is pleased to announce that it has signed a contract with its first customer to manufacture a sterile clinical trials drug product at its Sterile Product Development Center (SPDC) in Braine-l’Alleud, near Brussels.
The work on this peptide-based sterile drug product will include formulation and lyophilization development and manufacture of a pilot and GMP batches (active and placebo) of material for use in Phase I clinical trials as well as validation of analytical methods.
Stability studies in accordance with ICH (International Conference on Harmonisation) guidelines will be carried out, as well as the provision of regulatory information to support the investigations new drug application.
Sean Marett, Managing Director, Product Development Services, NextPharma Technologies commented ‘this is a great example of the breadth and level of our sterile manufacturing capabilities – and how our customers are benefitting from an integrated service provided by one company.’ Bill Wedlake, Chief Executive Officer, NextPharma Technologies added ‘our team in Braine l’Alleud has extensive lyophilization expertise stretching back nearly twenty years, they now also have one the finest development facilities in the world to support their extensive knowledge base and to be able to work with our customers in their development of new chemical and biological molecules.’
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.
Contact:
Bill Wedlake
Chief Executive Officer
NextPharma Technologies Holding Limited
Tel +44 (0) 1483 479 121
Notes to Editors:
About NextPharma
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.
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.
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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.