ITM Isotope Technologies Munich SE recently received the radioactive material handling license (RAM license) for the company’s NOVA facility, which the company calls the world’s largest lutetium-177 (Lu-177) production site.
Lu-177 is a medical radioisotope frequently used in radiopharmaceutical therapy to treat cancer. ITM said with the RAM license and other regulatory approvals, the company has achieved operational readiness. The license was granted by the Bavarian Environment Agency (LfU).
With the license, the company can begin radioactive operations onsite to qualify and validate all systems. This is a mandatory process needed to obtain pharmaceutical manufacturing authorization. The NOVA site's major production, safety, and quality control systems have been installed, and ITM has started quality control and waste management operations. The company also highlighted that the site, covering an area of about 7,000 m2, could potentially serve up to several hundred thousand patients worldwide per year.
