Germany’s ITM receives material license to produce Lu-177

ITM was granted a radioactive material handling (RAM) license for the NOVA facility by the Bavarian Environment Agency, the relevant regulatory body. Having obtained the license together with other regulatory required approvals, ITM said it has reached operational readiness for the facility, which was officially opened in June 2023.

According to the company, NOVA is the world’s largest production site for Lu-177, which is frequently used in radiopharmaceutical therapy for the treatment of cancer.

Hot commissioning: The RAM license grants ITM the approval to begin radioactive operations at NOVA with the purpose of qualifying and validating all systems, a mandatory process needed to obtain the pharmaceutical manufacturing authorization.

According to ITM, 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.

ITM said that the 7,000-square-meter NOVA facility will be instrumental to the company’s ability to meet the increasing global demand for radiopharmaceuticals used for cancer treatment by significantly expanding ITM’s 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, according to ITM.

He said it: “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,” said Steffen Schuster, ITM chief executive officer. “This is a critical achievement that brings us one step closer to full-scale manufacturing at NOVA.”