ARTMS Inc. is pleased to announce the submission of a Drug Master File (DMF) to the FDA for the high-volume production of Gallium-68 (68Ga) with ARTMS’ solid target technology in combination with a medical cyclotron. ARTMS’ proprietary QUANTM Irradiation system (QIS) demonstrated world record production of over 10 Ci 68Ga in 2019 on a low energy cyclotron. These low energy cyclotrons are installed in hundreds of sites globally where the QIS can be installed for daily use.
“This submission to the FDA demonstrates how the team at ARTMS is executing our strategy. The molecular imaging community has and will continue to develop a number of innovative agents that are labeled with 68Ga. Unfortunately, the current supply chain of germanium/gallium generators is not robust enough to meet projected demand for these products. The action taken today by ARTMS marks a significant step toward solving the forthcoming supply issues for this critical isotope. ARTMS has spent the last 18 months solidifying partnerships with drug developers and building a network of cyclotron operators with the intention of changing the way isotopes are delivered to patients in greatest need of these imaging studies. The ARTMS platform goes far beyond 68Ga production, expanding our client’s reach to other high demand diagnostic and therapeutic isotopes. I am extremely excited about the opportunity that is in front of ARTMS and our partners,” says Charles S. Conroy, Chief Executive Officer of ARTMS.
The use of 68Ga labelled products is among the most important innovations in the history of nuclear medicine. Currently, 68Ga radiopharmaceuticals are used to identify and stage a variety of oncology conditions, including neuroendocrine tumors and prostate cancer. This isotope has been traditionally supplied by generators which have limited output capabilities and are logistically and economically burdensome. While generators will continue to be a part of the 68Ga supply chain, ARTMS’ technology will alleviate widespread shortages as demand increases for 68Ga labelled diagnostic agents.
“It is our strategy to work alongside the radiopharmaceutical innovator community to allow the ARTMS solution and associated regulatory filings to be included in the innovator’s investigational new drug and new drug applications,” said Dr. Michael Cross, Chief Operating Officer and project lead at ARTMS. “Moving forward, ARTMS will continue to expand collaboration efforts with the radiopharmaceutical innovators to validate ARTMS’ 68Ga with these important medical products."
With a focus on optimizing production potential, ARTMS will continue the development of cyclotron-produced 68Ga and other vitally important medical isotopes, while also pursuing multiple regulatory approvals. ARTMS has a variety of solid targets commercially available used in combination with ARTMS’ QUANTM Irradiation System (QIS).Back To Top
ARTMS Submits DMF for High-Volume Production Of Gallium-68. Appl Radiol.