Through Vial Impedance Spectroscopy installed at GEA Lyophil, Hürth, Germany

TVIS is based on well-known principles of impedance spectroscopy, however, this is the first time that impedance spectroscopy has been used to characterize materials within conventional glass freeze-drying vials, without having to insert the electrodes into the product, to provide a technique which is non-invasive to both the product and process.

De Montfort University’s TVIS prototype has been successfully translated into a commercially viable instrument through our work with a specialist instrumentation company, Sciospec Scientific Instruments GmbH (Leipzig).

At the beginning of November, Geoff Smith visited GEA Lyophil in Hürth (near Cologne) to participate in the installation of TVIS technology on GEA’s development scale freeze dryer. The successful trial paves the way for GEA to begin using the technology in the development of production cycles for their clients in the biopharmaceutical industry. It is expected that the increased process understanding delivered by TVIS will accelerate product development and facilitate the creation of more stable products and more efficient manufacturing cycles, resulting in new drugs coming to market sooner and at reduced cost.

The GEA Lyophil installation follows three earlier installations of TVIS prototypes the National Institute of Biological Standards and Control (NIBSC) in South Mimms, Potters Bar (Oct 2015) and at Sanofi in Waterford, Ireland (Nov 2016).