ARTMS, a Canadian producer of medical isotopes has registered the cyclotron production of gallium-68 with the government of Canada, filing a Type 1 Master File with the Health Products & Food Branch of Health Canada.
The Ga-68 radioisotope is used in nuclear medicine diagnostic procedures utilizing positron emission tomography (PET) imaging. ARTMS said the filing will help alleviate the current Ga-68 supply constraints and provide innovators the ability to advance new radiopharmaceutical drugs into development.
ARTMS has also entered into a three-party cooperation for the development and clinical use of innovative radiopharmaceuticals in Canada. The partners joining ARTMS are POINT Biopharma and the Canadian Molecular Imaging Probe Consortium, or CanProbe, a joint venture between the Centre for Probe Development and Commercialisation and the University Health Network.
“The Ga-68 regulatory filing in Canada is the next step in ARTMS’ goal to prevent the significant supply issues of this important medical isotope,” said ARTMS CEO Charles S Conroy. “The current supply chain of germanium/gallium generators is inefficient, high cost, and at risk for interruption at any time.”
Joe McCann, CEO of POINT Biopharma, added, “Increasing the availability and scale of Ga-68 supply through cyclotron production will be important in further accelerating the development and commercialisation of next-generation radiopharmaceutical therapies. We believe ARTMS’ solid target approach to Ga-68 production will play a key role in increasing the availability of this important isotope.”