NextPharma Technologies Opens New Clinical Trials Services at its Göttingen Site in Germany

Surrey, UK, 4th December, 2008

NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotech industry, is pleased to announce the opening of a major new Clinical Trials Services (CTS) facility in Göttingen, Germany to meet the growing demand from customers and to provide customers with the latest advances in the services of a premier CTS facility.

The new facility has extensive capacity in packaging suites for primary and secondary packaging and an extended cold storage area (2-8 °C and - 20 °C). It has a dedicated packaging suite for secondary packaging of high potency drugs, such as cytotoxics and the capability to perform primary packaging under inert gas conditions. Moreover, a dedicated suite for the packaging of humidity sensitive investigational medicinal products is also available. 

In conjunction with the opening this new CTS facility, NextPharma has invested in additional project management resource to provide dedicated project support at the highest level to individual customer requirements.   

These new CTS facilities have been designed specifically to meet the needs of pharma, biotech, universities and contract research organisations. As well as providing packaging and distribution services for non clinical, Phase I and Phase II clinical trials, the new facility can also offer greater packaging and distribution capacity for large Phase III and IV trials.  It operates to strict cGMP guidelines, meets all European compliance regulations and is in the process of being validated to meet FDA regulatory requirements.

Sean Marret, Managing Director, NextPharma Technologies, Product Development Services commented: ‘The opening of this unit marks a significant milestone in the expansion of our Clinical Trials Services business in response to the current market where cost pressure and the growing complexity of trials is forcing drug makers to turn increasingly to outsourcing experts for clinical development support’.

Bill Wedlake, CEO, NextPharma added: ‘The opening of this ‘state of the art’ facility represents a major step for NextPharma towards meeting our objective to be a leading provider of World Class, clinical research services to pharma, biotech, academic and research organisations through the provision of quality product development and contract manufacturing services’.  

NextPharma is a leading provider of CTS and provides formulation development, manufacturing of investigational medicinal products, packaging design, comparator procurement, blinding, primary and secondary packaging, analytics, stability testing and microbiology testing, methods development and methods validation.  Our highly experienced teams handle a variety of pharmaceutical forms for Phase I –IV clinical trials in accordance with Annex 13 EU-GMP guidelines in Europe and FDA guidelines in United States. In addition our services are supported in Europe by our dedicated Qualified Persons, who provide release testing of clinical material from outside Europe.  

NextPharma develops, manufactures, packages and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones and controlled release medicines. It  has an established leadership position in the high technology area of injectables manufacturing, with particular expertise in product development and manufacture of oncology medicines.

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