Isotope Technologies Garching received manufacturing authorization for Ga-68 Generator

ITM Group affiliate Isotope Technologies Garching GmbH is proud to announce that it obtained the manufacturing authorization for its pharmaceutical grade Ge-68/Ga-68 Generator. The approval by the regional government of Upper Bavaria came in December 2014, allowing ITG to provide the only metal-free Gallium-68 Generator to a fast growing market of positron emission tomography (PET) scan procedures.

Innovative Gallium-68 platform

PET imaging with Gallium-68 labeled tracers has proven to be a superior method for precise localization of tumors and metastatic lesions. Compared to cost expensive alternatives such as radiolabeled Fluor-18 which requires an in-hospital cyclotron, Gallium-68 can be conveniently eluted from the Ge-68/Ga-68 Generator and directly utilized for the radiolabeling with target molecules. What is more, the autoclaved itG Ge-68/Ga-68 Generator provides a sterile eluent in order set highest safety standards.

In fact, the novel GMP compliant Ge-68/Ga-68 Generator is part of ITG's overall business strategy to establish a solid Gallium-68 platform. Steffen Schuster, CEO at Isotope Technologies Garching GmbH emphasizes: "We feel proud to have set yet another important milestone in order to further strengthen the role of Gallium-68 as next generation radioisotope for diagnostics. The self-shielded iQS Ga-68 Fluidic Labeling Module also contributes to our innovative Gallium-68 platform as it makes the preparation of Gallium-68 labeled tracers as fast and convenient as never before."

Living Theranostics

Apart from diagnostics, the ITM Group is also boosting the development of therapeutic radioisotope treatments. Since 2011, no-carrier-added (n.c.a.) Lutetium-177 is manufactured in GMP quality at independent production facilities around the world. Lutetium-177 n.c.a. is a first-in-class radioisotope for the therapy of serious and difficult to treat oncological diseases. In combination with Gallium-68 for the prior diagnosis and localization of malignant lesions, this theranostic platform is leading the way to further develop personalized medicine.

About the ITM Group

The ITM Group is a privately held group of specialized radiopharmaceutical companies dedicated to the development of innovative radioisotopes, radiopharmaceuticals and next generation radiomedical devices. The ITM Group is strengthening its innovative theranostic platform also by reaching strategic alliances with leading partners in the industry. For this reason, the ITM Group is encouraging other pharmaceutical companies to further invest in potential innovations in order to develop new treatments that bring real added value to the wellbeing and quality of life of patients.

Full release: http://itm.ag/media-relations/itm-group-news.html


Christopher Morin

Manager Marketing & Corporate Communications