ITM, a radiopharmaceutical biotech company, announced it received a Radioactive Material Handling License (RAM License) for its NOVA facility, the world’s largest Lutetium-177 production site.
Lutetium-177 is an innovative medical radioisotope frequently used in Radiopharmaceutical Therapy (RPT) for the treatment of cancer.
The RAM License has been granted by the Bavarian Environment Agency (LfU), the relevant regulatory body, in line with the highest quality standards. Having obtained the RAM License together with other regulatory approvals required, ITM has achieved operational readiness.
NOVA will allow us to provide cancer patients with high-quality medical radioisotopes needed for precision oncology diagnostics and treatments
The CEO of ITM, Steffen Schuster, said: “Our rapid progress in commissioning the NOVA site, only eight months after opening the facility, demonstrates our team’s focus and ability to deliver on our corporate objectives. Lutetium-177, NOVA will allow us to provide cancer patients with high-quality medical radioisotopes needed for precision oncology diagnostics and treatments.”
The RAM License grants ITM the approval to start ‘hot commissioning’, meaning the start of radioactive operations on site with the purpose of qualifying and validating all systems, a mandatory process needed to obtain the pharmaceutical manufacturing authorisation.
The fit out of NOVA has been completed, with all major production, safety and quality control systems installed. In addition, ITM has initiated quality control and waste management operations.
NOVA will be instrumental to ITM’s ability to meet the rapidly increasing global demand for radiopharmaceuticals used for cancer treatment by allowing ITM to significantly expand its capacity to supply clinics, pharmaceutical partners, and its own radiopharmaceutical pipeline. Based on its size and production scale, NOVA could potentially serve up to several hundred thousand patients worldwide per year.
This facility covers an area of approximately 7,000 sqm and operates at an industry 4.0 technical level, featuring a high degree of automation in production processes and internal logistics. and offers cleanrooms, laboratories and offices that can be used by up to 200 employees for radiopharmaceutical manufacturing meeting the highest level of quality standards.