Partial Germanium-68 (Ge-68) Production Withdrawal

Among the many radioisotopes, the Department of Energy's Isotope Program has been producing and distributing germanium-68 (68Ge) for research and commercial applications for many years. Germanium-68 has a half-life of 271 days and decays to the radionuclide gallium-68 (68Ga, half-life 68 minutes). Germanium-68 has been mainly utilized as a reference source for the calibration and normalization of 2D and 3D Positron Emission Tomography (PET) imaging systems. In recent years, the 68Ge/68Ga generator system has attracted increasing interest as an excellent device to provide the short-lived radioisotope 68Ga. The positron-emitting 68Ga can be easily eluted from the 68Ge/68Ga generator system, and utilized for the radiolabeling of peptides and other molecules used in diagnostic applications in nuclear oncology, such as neuroendocrine tumor imaging. Recently, the pharmaceutical 68Ge/68Ga generator has received European approval for the clinical development of highly specific diagnostic agents, thus potentially facilitating the development and applications of 68Ga technologies.

With its reliable production and supply of 68Ge over the past years, the DOE Isotope Program has met the continuously increasing market demand and has enabled the research community to develop new, promising devices for cancer diagnostics. The prospects of the increasing utilization of 68Ga in diagnostic PET procedures have made the commercial production of 68Ge a viable enterprise and the DOE Isotope Program has now successfully transferred some Ge-68 production responsibility to the private sector.

The DOE Isotope Program recently conducted a rigorous process to evaluate domestic production capacities and their ability to reliably and economically meet domestic market demand. At the end of the assessment, and in consideration of community input, the DOE Isotope Program concluded that the demand for 68Ge for the fabrication of PET calibration sources was adequately satisfied with the addition of a new domestic producer. However, without the production of 68Ge by the DOE Isotope Program for use in 68Ge/68Ga generators, a sole domestic commercial producer would not represent effective competition in the supply of 68Ge in support of the Nation's best interests in the research and development of 68Ga radiopharmaceuticals. As a result, the DOE Isotope Program announced in the Federal Register (79 FR 51985, September 2, 2014), that it will withdraw from the distribution of 68Ge for the manufacturing of PET calibration sources, but continue in the production and distribution of 68Ge for use in the manufacture of 68Ge/68Ga generators. In all cases, the DOE Isotope Program will make customers aware of the new domestic production capabilities and encourage customers to consider alternate suppliers to the DOE. The DOE Isotope Program's 68Ge customers will be required to sign an end-use statement to assure that the 68Ge will be used only in the fabrication of 68Ge/68Ga generators. Further details are provided in the Federal Register notice

The DOE Isotope Program develops isotope production and nurtures applications of isotopes until such time as private industry develops the technology and is able to meet the needs of the community. The DOE Isotope Program does not compete with private industry for isotope production when commercial isotope production can meet domestic demand in a reliable and cost-effective manner, and in the context of effective competition. The partial transfer of the production and distribution of 68Ge to the private sector is considered a story of success by the DOE Isotope Program, and indicative of a successful nurturing of this isotope within the medical community, until its production became economically viable for industry. The transfer of 68Ge production to the private sector becomes the latest success that began with the Manhattan Project's 1946 shipment of carbon-14 to researchers, and includes the development of the molybdenum-99/technetium-99m generator system, the most widely used medical diagnostic isotope in the world.