The Lu-177 was produced using the isotope production system (IPS) that was recently installed in Unit 7 of Bruce Power’s CANDU nuclear power plant in Ontario during a recent planned maintenance outage. As part of the commissioning of the IPS, ytterbium-176 targets were irradiated to produce Lu-177, which were then sent to ITM in Germany for processing.
In announcing the milestone on June 21, Bruce Power said that IPS commissioning activities will be completed this summer and will be followed by commercial operations, pending final regulatory review and approval by the Canadian Nuclear Safety Commission.
The isotope: A medical isotope used in precision oncology for targeted therapy of a growing number of cancers, Lu-177-based treatments are designed to precisely target malignant cells while sparing surrounding healthy tissues.
Using its proprietary manufacturing methodology and industrial-scale production capacities, ITM will process the IPS-produced Lu-177 to yield high-quality, pharmaceutical-grade, no-carrier-added (n.c.a.) Lu-177, which ITM provides to health care facilities around the world. N.c.a. Lu-177 has been used in various clinical and commercial radiopharmaceutical cancer treatments. ITM holds a Drug Master File with the U.S. Food and Drug Administration for n.c.a. Lu-177 and has marketing authorization in the European Union (brand name, EndolucinBeta).
ITM will have exclusive access to the IPS irradiation services to produce Lu-177, and Bruce Power will market the new isotope supply in a historic collaboration partnership with Saugeen Ojibway Nation.
They said it: “Bruce Power and our partners at Isogen, ITM, and Saugeen Ojibway Nation are thrilled to have reached this exciting milestone, bringing our partnership project to its final phase as we complete commissioning and approach commercial operations,” said James Scongack, Bruce Power’s chief development officer and executive vice president of operational services. “Today’s announcement is the culmination of years of hard work by hundreds of dedicated people and we are proud to demonstrate the power of using Bruce Power’s CANDU reactors to provide large-scale, reliable production of critical medical isotopes to use in the fight against cancer.”
“This cutting-edge, first-of-its-kind irradiation site is the result of the combined expertise of Bruce Power, Isogen and ITM, the great commitment of our partners, and our joint belief in the importance of lutetium-177 in novel cancer therapy,” said Steffen Schuster, chief executive officer at ITM. “The exclusive access to the new isotope production system will allow ITM to further scale our global pharmaceutical n.c.a. lutetium-177 production, which is critical to meet the growing demand of high-quality medical isotopes for use in targeted radionuclide therapy for cancer patients worldwide.”
