ARTMS Inc. (ARTMS) 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 at hundreds of sites globally, where the QIS can be installed for daily use.

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.

To read more please visit:

http://artms.ca/artms-inc-submits-drug-master-file-for-the-first-ever-multi-curie-production-of-gallium-68-with-artms-solid-target-solution-on-medical-cyclotrons

Source: ARTMS