September 3, 2021 — Eckert & Ziegler Radiopharma GmbH has successfully submitted an amendment to their Drug Master File (DMF) to the U.S. Food and Drug Administration for GalliaPharm. Their proprietary Ge-68/Ga-68 generator from now on will additionally be available in sizes of up to 100 mCi with a shelf-life of 12 months or for a maximum of 700 elutions. Gallium-68 from GalliaPharm is used for the preparation of diagnostic imaging drugs in Positron Emission Tomography (PET).
“With the development of generators with higher Ge-68 activity and the amendment of our DMF, we are responding to the increasing demand for Ga-68 based diagnostics in the United States,” explained Dr Harald Hasselmann, Eckert & Ziegler Executive Director and responsible for the Medical segment. “The soon to be available preparations for imaging of prostate cancer as well as upcoming novel Ga-68 drugs and their theranostic pair, mostly labeled with Lu-177, allow Eckert & Ziegler to strongly support the trend towards higher activity generators and we are currently working to provide comprehensive solutions to the healthcare providers and their patients.”
“Higher activity GalliaPharm generators will enable nuclear medicine institutions and radiopharmacies across the United States to prepare their Ga-68 PET imaging products with the same flexibility as they are used to, while being able to offer the procedures to a greater number of patients and with an expanded service area,“ added Jay Simon, General Manager of Eckert & Ziegler Radiopharma, Inc. in Wilmington, MA. “Users can obtain additional doses from a single generator elution and are at the same time able to significantly increase the number of daily elutions. Both will contribute to enhanced medical care and assure the supply to American patients.”
GalliaPharm is mainly used in combination with tracer kits for diagnosis of neuroendocrine tumors and prostate cancer. Gallium generators offer a low-cost alternative for the radiolabeling of biomolecules with Gallium-68 in PET, an imaging examination method used to detect the presence or absence of diseased tissue. PET imaging is primarily used in the diagnosis of cancer, cardiology or neurology. Radioisotopes such as Fluorine-18 can be used alternatively but require investments of millions of dollars in large-scale equipment (cyclotrons). The Ge-68/Ga-68 generator on the other hand, is an easily transportable, small system that is much more cost-efficient, leading to cost reductions for nuclear medicine providers while increasing flexibility.
For more information: www.medical.ezag.com