Eight months after opening, ITM Isotope Technologies Munich SE’s NOVA facility, which will be the largest production factory in the world for non-carrier-added lutetium-177, has been declared operationally ready.

The company received its Radioactive Material Handling License (RAM License) from the Bavarian Environment Agency (LfU), giving it the green light to begin hot commissioning, the process for starting radioactive operations on-site to qualify and validate the functions of all systems, a necessary requirement for obtaining the pharmaceutical manufacturing authorization.

Lu-177 is a therapeutic radioisotope that can be used as part of a targeted radionuclide therapy to treat various cancers, including neuroendocrine tumors and certain metastatic prostate cancers. Located in Neufahrn near Munich, in Bavaria, Germany, the facility will increase ITM’s capacity tenfold to supply clinics, pharmaceutical partners, and its own drug pipeline to cater to growing demands worldwide for the radioisotope. Based on its size and production scale, ITM says NOVA could potentially produce radiopharmaceuticals for up to several hundred thousand patients worldwide annually.
“This is a critical achievement that brings us one step closer to full-scale manufacturing at NOVA. Along with solidifying our position as the world’s largest manufacturer of n.c.a. Lutetium-177, NOVA will allow us to provide cancer patients with high-quality medical radioisotopes needed for precision oncology diagnostics and treatments,” said Steffen Schuster, CEO of ITM, in a statement.

The facility, which opened in the first half of 2022, will work in conjunction with ITM’s existing factory IAZ at the main site in Garching near Munich, where the company set up a new production line in October 2022, multiplying its capacity for manufacturing non-carrier-added Lu-177.

The 7,000-square-meter site is in NOVA Neufahrn industrial park, near Munich Airport for quick shipments, and will have 200 employees in research, radiopharmaceutical manufacturing, and aseptic production, along with clean rooms, laboratories, and offices. Its production processes and internal logistics will operate at an industry 4.0 technical level, making them highly automated, according to ITM.

The fit-out of the facility has been completed, with all major production, safety, and quality control systems installed. ITM has also initiated quality control and waste management operations.

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