ARTMS has submitted a drug master file to the Health Products and Food Branch of Health Canada for the production of gallium-68 (Ga-68).
Ga-68 is a medical isotope of significant clinical importance in nuclear medicine diagnostic procedures utilizing PET imaging.
The current supply chain of germanium/gallium generators is inefficient, high cost, and at risk for interruption at any time, according to ARTMS officials. Approval to produce Ga-68 will help alleviate current supply constraints and provide innovators with the ability to advance new radiopharmaceutical drugs into development, the company said.
On the basis of the filing, ARTMS has also entered into a tri-party agreement with fellow industry leaders Point Biopharma and the Canadian Molecular Imaging Probe Consortium (CanProbe), for the development and clinical use of innovative radiopharmaceuticals in Canada. CanProbe is a joint venture between the Centre for Probe Development and Commercialization and the University Health Network.
