Eckert & Ziegler obtains manufacturing authorization for pharmaceutical Gallium-68 generators

08-06-2012: Eckert & Ziegler Radiopharma GmbH, a subsidiary of Eckert & Ziegler AG, has been given the manufacturing authorization for its pharmaceutical 68Ge/68Ga generators at the newly-built, GMP-compliant manufacturing facilities in Berlin. The authorization given by the local German competent authority allows the manufacture of pharmaceutical 68Ge/68Ga generators for use in clinical studies.

68Ge/68Ga generators enable Gallium-68 radionuclide production for use in Positron Emission Tomography (PET). The radionuclide can be coupled with a multipurpose diagnostic biomolecule to locally create ready-for-use pharmaceuticals used in PET scan diagnoses. Currently, clinical uses of Gallium-68-labelled diagnostic pharmaceuticals are mostly in oncology. However, vast strides have been made in the development of pharmaceuticals in cardiology and in degenerative nerve diseases. In contrast to Fluorine-18 or Carbon-11-based PET diagnostics, Gallium-68-based technology does not require the use of expensive cyclotrons, thereby reducing costs and enabling increased flexibility in the practice of nuclear medicine diagnostic imaging.