News
Eckert & Ziegler Receives Manufacturing Authorization for GMP-grade Lutetium-177
20.04.2023 / Eckert & Ziegler Radiopharma GmbH, a subsidiary of Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700, TecDAX), has received the manufacturing authorization for Lutetium-177 (non-carrier-added Lu-177) in GMP grade from the competent German authority. The approval is the basis for the marketing authorization of Lutetium-177 as a drug, but also for use of this radioisotope as a starting material for the manufacture of radiopharmaceuticals. By making Lutetium available to a significantly broader range of users, the approval will enable Eckert & Ziegler to further continue its successful strategy as one of the world leading isotope suppliers.
Lutetium-177 based radiopharmaceuticals are well established for the treatment of neuroendocrine tumors and prostate cancer. Numerous other radiotherapeutics for various cancer types are currently under development and evaluated in clinical trials, which is why experts expect a strong increase in demand for the radioisotope.
“Following our recent DMF submission in the USA, this approval is another indispensable component to further expand the supply of Lutetium-177 to pharmaceutical companies and customers around the world,” explained Dr. Lutz Helmke, member of the Executive Board and responsible for the Medical segment at Eckert & Ziegler. “We will not only meet the increasing demand in general, but also use the radioisotope for contract development and manufacturing activities that we are setting up for partners in our facilities in Europe, North America and Asia."
The beta emitting Lutetium-177 is linked to a tumor specific ligand which then targets the tumor cells to destroy them. A major advantage of Lutetium based drugs is that they are used in a theranostic approach. The same ligand of the radiotherapeutic will be linked to a diagnostic radioisotope such as Gallium-68. With the help of so-called PET scanners, the patient's response rate and thus the benefit of a treatment can be predicted in advance with high precision.
Source: Press Release EZAGEckert & Ziegler Receives Manufacturing Authorization for GMP-grade Lutetium-177
