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Radioisotopes

Since our founding in 2004, we have continued to be a reliable, and high-quality supplier of radioisotopes. Our vertically integrated approach, which combines a solid foundation in radioisotope supply with an innovative radiopharmaceutical pipeline, enables us to continue to play a leading role in the promising and evolving field of radiopharmaceuticals. We are constantly expanding our capabilities in the manufacture and supply of novel radioisotopes, thereby advancing our position as a leading global supplier of non-carrier-added (n.c.a.) Lutetium-177 (Lu-177) and Actinium-225 (Ac-225).

Unique manufacturing capabilities for n.c.a. Lu-177

Lu-177 is a beta-emitting radioisotope used as an active component in cancer-targeting radiopharmaceuticals. Among known producers, ITM owns the world’s largest production facility for GMP-grade n.c.a. Lu-177. ITM has secured large stocks and a reliable supply of Ytterbium-176 (Yb-176), a rare element used as critical raw material in the manufacturing of n.c.a. Lu-177. Additionally, in alignment with ITM's commitment to sustainability, our efficient recycling process for Yb-176 minimizes the loss of this critical component. Our patented manufacturing process is executed and controlled by a team of highly experienced experts, assuring strict compliance with GMP-standards and applicable regulations. 

Press release "ITM Opens World's Largest Lutetium-177 Production Facility for Targeted Radionuclide Therapies Against Cancer" (06/2023)

Our n.c.a. Lu-177 product EndolucinBeta® is manufactured to GMP standards, has EU Marketing Authorization, and an active US FDA Drug Master File (DMF) is available. We use a specialized, indirect production method that starts with highly enriched Ytterbium-176 (Yb-176). In a reactor Yb-176 captures a neutron to form Yb-177, which then decays to Lutetium-177 (Lu-177), producing no-carrier-added (n.c.a.) Lu-177. This indirect route yields very high specific activity and excellent radionuclidic purity (the short-lived Yb-177 intermediate quickly decays to Lu-177, while Yb-176 can be recycled to be used again). By contrast, carrier-added (c.a.) Lu-177 is produced by directly irradiating Lu-176 (the “direct” method). That route yields Lu-177 together with residual Lu-176 and the metastable isomer Lu-177m (a long-lived impurity with a half-life of ≈160 days). These impurities are hard to remove, reduce the achievable specific activity, can compete with Lu-177 during radiolabelling, and complicate radioactive waste handling. 

Find out more about the difference between c.a. and n.c.a. Lu-177 (for healthcare professionals)

We supply n.c.a. Lu-177 worldwide to clinics, academic researchers and biopharmaceutical companies located in more than 60 countries. ITM benefits from a well-established logistics network, ensuring priority shipments within 24–48 hours across the European Union and the United States, and within 72 hours to other international destinations. Through reliable, longstanding partnerships with nuclear reactors we can provide security of supply and daily availability of Lu-177.

Reliable irradiation capacities

We are especially proud to be part of an international collaboration with Bruce Power, Isogen, and the Saugeen Ojibway Nation. This collaboration has in 2022 successfully completed the installation of a new isotope production system at the Bruce Power nuclear facility in Ontario, Canada. This first-of-its-kind system is capable to irradiate the raw material Yb-176 during operation of a commercial nuclear power reactor, marking a major milestone in the supply of Lu-177 and providing ITM with extensive, all year-round irradiation capacity. This initiative reflects ITMs strong commitment to advancing global access to medical isotopes, particularly Lu-177, used in targeted cancer therapy. 

Press release “ITM: New Isotope Production System at Bruce Power Successfully Produces First Medical Isotope" (06/2022)


Press release “Saugeen Ojibway Nation, Bruce Power, Isogen and ITM double down on production of cancer-fighting medical isotopes" (10/2024)

Actinium-225 (Ac-225) is an alpha-emitting radionuclide currently under investigation for use in targeted radiotherapeutic applications. In 2023, ITM founded the joint venture Actineer together with Canadian Nuclear Laboratories (CNL) to pioneer the commercial scale production of Ac-225 based on cyclotron irradiation of Radium-226 (Ra-226) targets with protons. This method provides an alternative to Thorium-229 (Th-229) generator-based approaches and is being developed to build a scalable and consistent supply for global patientcare. 
The production of Ac-225 builds on ITM’s and CNL’s over 100 years of cumulative experience in the fields of nuclear science, radiochemistry and radiopharmacy, and Actineer’s large quantities of Ra-226. This supports the development of infrastructure, processes, and quality systems necessary for reliable and scalable supply. Our objective is to contribute to the availability of Ac-225 for use in research and potential future medical applications, in line with applicable regulatory frameworks.