ITM Isotope Technologies Munich SE (ITM) opened its new production facility for Lutetium-177 for targeted radionuclide therapies against cancer. The new manufacturing plant in Neufahrn near Munich, Germany increases ITM's production capacity tenfold. It is the world’s largest production site of lutetium-177, an innovative medical isotope used in targeted cancer therapies.
The ceremonial opening of the new NOVA production facility for the manufacture of therapeutic radionuclides took place together with State Minister Dr. Florian Herrmann, Head of the Bavarian State Chancellery, and other high-ranking guests on site in Neufahrn near Munich. The new manufacturing facility increases ITM's production capacity tenfold and is the world's largest facility for the production of lutetium-177.
Technologically at the state of the art of Industry 4.0, the new production site achieves a high degree of automation in the production process and internal logistics on an area of around 7,000 m2. The new site offers clean rooms, laboratories and offices that can be used by up to 200 employees for research as well as radiopharmaceutical manufacturing and aseptic production with the highest quality standards.
Due to its medical properties, lutetium-177 has gained importance in precision oncology treatments internationally as a valuable starting material for the production of various radiotherapeutics in recent years. Once the new NOVA production facility is fully operational, ITM will increase its capacity to supply clinics, pharmaceutical partners and its own drug pipeline tenfold. This will help ITM meet the rapidly growing demand for radiopharmaceuticals used in patient care worldwide.
"Radiopharmaceuticals are an essential new class of anti-cancer drugs that have the potential to improve therapy outcomes and quality of life for many patients. ITM's additional production site is an important contribution to medical research and drug supply for patients in Germany and worldwide," said Udo J. Vetter, Chairman of the Supervisory Board of ITM and Chairman of the Advisory Board of Vetter Pharma. "Equipped with state-of-the-art manufacturing facilities and expertly trained employees, ITM has the knowledge and the skills to take on this important responsibility and to meet the highest quality and safety standards for patients at all times - with innovative cancer drugs made in Germany."
ITM will operate the new production site at NOVA Neufahrn industrial park in addition to its existing manufacturing facility IAZ at the main site in Garching near Munich. All technical authorization processes required for commissioning as well as official approvals have been initiated or are scheduled. The first test runs of the facility are planned to begin within the next few months, with final official approvals expected in 2024.
The development and production of medical radioisotopes by ITM was enabled, in part, by years of collaboration with the Garching Research Reactor (FRM II) and the Technical University of Munich (TUM).