Adds ModuC LS IPC capsule filling machine at Göttingen, Germany
NextPharma 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 solid and liquid products. Currently it has filling stations for powders, granules, pellets, tablets, capsules and micro tablets. Further filling stations can be added, depending on demand. They can be operated individually or in combination enabling a wide range of filling possibilities. As a result of this flexibility NextPharma can encapsulate and over-encapsulate investigational medicinal products at speeds of up to 20,000 units/hour. The machine also has 100% online weight control of each capsule.
According to Sean Marett, managing director, NextPharma Technologies, Product Development Services (PDS) this new machine compliments the 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. 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.
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.
NextPharma also has Clinical Trials Services capabilities at its FDA-inspected San Diego, California, US facility, which mirror the Göttingen CTS plant.