Monrol Will Establish a Legal Entity and Manufacturing Facility in Germany
The new facility will focus on the manufacture of SPECT products and radiopharmaceutical products for radioligand therapy(*) such as Gallium-68 generator and n.c.a Lutetium-177. Developed by Monrol R&D teams, these products are widely used in the production of radiopharmaceuticals for cancer patients. The facility will also have a dedicated division for state-of-the art cGMP Contract Development and Manufacturing Organization (CDMO) services.
Monrol plans to make the site a center of excellence for both radiopharmaceutical production and scientific and industry collaborative efforts to create innovations. The facility is expected to be up and running by 2026 at an estimated cost of around 30 million euros.
(*) Targeted radioligand therapy is an innovative approach to cancer treatment that is considered to be one of the most remarkable and advanced therapies currently under study. Multiple clinical development programs and clinical trials around the world are testing this approach for various cancer types.
About Lutetium-177 n.c.a
Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients. Unique properties of Lutetium-177 n.c.a make it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like neuro endocrine tumors (NET) and prostate cancer; many clinical development programs are also testing the therapy for other cancers like ccRCC.
A gallium-68 generator is a device used to extract the positron-emitting isotope 68Ga of gallium from decaying germanium-68. The parent isotope 68Ge is easily utilized for in-hospital production of generator-produced 68Ga. Its decay product gallium-68 is extracted and employed in certain positron emission tomography nuclear medicine diagnostic procedures used for the diagnosis of cancer patients and direct tumor imaging.
Monrol is one of the world’s largest nuclear medicine companies and a leader in the development and manufacturing of GMP grade radioisotopes and radiopharmaceuticals. The company distributes its own portfolio of world-class radiopharmaceutical products to more than 50 countries around the globe from its headquarters in Istanbul. Committed to transforming and improving patient journeys in cancer treatment, Monrol also provides early development support to CDMO customers as well as fully integrated services for taking new product concepts into clinical trials, demonstrating proof of concept, and moving into first-in-human studies. Located near a major international airport and transportation hub, Monrol benefits from a worldwide logistics network and agreements with cargo services to 320 destinations worldwide. To learn more, visit www.monrol.com and LinkedIn.
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