An international collaboration marking the start of commercial production of lutetium-177 was celebrated in Munich between Canada-based Bruce Power, Isogen and Isotope Technologies Munich (ITM).
The announcement was celebrated along with representatives of the partnership organizations during a trade mission with Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade.
This milestone was achieved following completion of final commissioning and regulatory approval from the Canadian Nuclear Safety Commission and is the culmination of a multi-year project to install an Isotope Production System (IPS) in Bruce Power’s Unit 7.
Precision nuclear medicine
It marks the first-of-its-kind achievement of a commercial power reactor with additional capability to commercially produce short-lived medical isotopes.
The IPS will provide reliable, industrial-scale production of lutetium-177, a medical isotope used for targeted cancer therapeutics. Lutetium-177 is used to deploy precision nuclear medicine that precisely targets malignant cells while sparing surrounding healthy tissues.
“Ontario’s nuclear industry supports thousands of high-skilled jobs and is at the forefront when it comes to innovation,” said Premier Doug Ford.
“Today’s announcement is a huge step forward in advancing Ontario as a world leader of isotope production in the fight against cancer. This unique international project using Made-in-Ontario infrastructure will help doctors and patients at home and around the world have greater access to the life-saving isotopes they need.”
Years of dedication
Mike Rencheck, Bruce Power’s president and CEO said: “It is with great pride that we at Bruce Power, along with our partners at Isogen, ITM and Saugeen Ojibway Nation, celebrate the successful commencement of commercial operation of the world’s first large-scale Isotope Production System for the production of lutetium-177.
“This announcement is the result of years of dedication and comes thanks to the hard work and innovative spirit of thousands of employees across this unique international partnership.”
The IPS irradiates ytterbium-176 to produce lutetium-177, which is then transported to ITM’s manufacturing facility in Germany for processing of pharmaceutical-grade, non-carrier-added lutetium-177 (n.c.a. lutetium-177).
Cancer treatments
ITM is a supplier of n.c.a. lutetium-177 to health care facilities around the world, and the isotope has been successfully used in various clinical and commercial radiopharmaceutical cancer treatments.
“Today we celebrate the efforts of Bruce Power, ITM, our Kinectrics staff, and our partner in Isogen, Framatome, whose collective efforts enabled the start of commercial supply of lutetium-177,” said David Harris, CEO of Kinectrics.
“This day marks a paradigm shift in medical isotope supply wherein the international medical community can now depend on scalable, reliable, Canadian, power-reactor produced isotopes for their cancer treatments.”
Isotopes
The IPS says it will leverage Bruce Power’s continual operations 24 hours a day, seven days a week to provide a consistent and scalable supply of life-saving isotopes that will be used by doctors to treat cancer patients around the world.
Bernard Fontana, CEO of Framatome said: “We commemorate this historical accomplishment that promises potentially life-saving medical treatments for cancer patients.”
“Our shared vision with our Isogen partner Kinectrics, and Bruce Power, working with ITM, has led to this significant milestone. We are proud of our teams who have persevered to design, develop, install and implement this ambitious and complex project. As part of our Framatome Healthcare brand, we are honored to play a critical role in ensuring a reliable supply of isotopes, including lutetium-177, to the medical communities around the world.”
Marketing authorization
Commercial operation of the IPS will provide large-scale production of lutetium-177 at a time when global demand for these short-lived isotopes is on the rise. ITM holds a U.S. Drug Master File (DMF) with the FDA for n.c.a. lutetium-177 and has marketing authorization in the EU (brand name EndolucinBeta). ITM has exclusive access to the irradiation service provided by the IPS for the production of lutetium-177 and will use the increased supply of high-quality isotopes from the IPS to meet the growing demand by physicians and patients.
“As the largest global provider of high-quality n.c.a lutetium-177 for therapeutic cancer treatments we are always looking to expand our production network to secure supply to provide access to hospitals and patients worldwide, and this collaboration is a testament to this commitment,” added Steffen Schuster, CEO of ITM.
“We are grateful to our partners for this smooth scale up to commercial production which will ensure production security for our own phase 3 assets as well as our commitment to currently approved targeted radionuclide therapies leveraging lutetium-177.”
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