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 that it has enhanced its clinical trials services (CTS) facility in Göttingen, Germany, through the installation of a ModuC LS IPC encapsulation / over-encapsulation capsule filling machine.
The new machine is fully automated and capable of filling and over-encapsulating a wide range of solid and liquid products. At present it has filling stations for powders, granules, pellets, tablets, capsules and micro tablets. Dependent upon demand, further filling stations can be added. The filling stations can be operated individually or in combination, enabling a wide range of filling possibilities. As a result of this flexibility NextPharma can efficiently and cost-effectively encapsulate and over-encapsulate investigational medicinal products with a speed of up to 20,000 units per hour. The machine also has the additional security of having 100% online weight control of each capsule.
On this new addition Sean Marett, managing director, NextPharma Technologies, Product Development Services (PDS) commented: "This new machine complements our already extensive clinical trials services capabilities in Göttingen. As clinical trials become more complex, we are pleased to be in a position to meet strong market demand for fast, efficient and accurate encapsulation and over-encapsulation of investigational medicinal products and their comparators for both large and small clinical trials."
NextPharma's Göttingen clinical trials services facility was completed in December 2008 and has extensive capacity in packaging suites for primary and secondary packaging and an extended cold storage area (2°C-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.
NextPharma's Göttingen clinical trials services facility has been designed specifically to meet the needs of pharmaceutical, biotechnology, contract research organizations and universities. As well as providing packaging and distribution services for non clinical, Phase I and Phase II clinical trials, the 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. Collectively the team at Göttingen has over 30 years' experience of providing clinical trials services.
NextPharma also has clinical trials services capabilities at its FDA-inspected San Diego, California, US facility which mirror its Göttingen CTS facility.
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers from tablets and capsules to antibiotics, hormones, steriles 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.
NextPharma has recently been acquired by Sun European Partners with a view to leveraging NextPharma's strong track record, reputation and state-of-the-art facilities, to grow the business both organically and by acquisition.
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