Isotopia Molecular Imaging ltd. is pleased to announce that it has filed a Drug Master File (DMF) with the U.S. FDA for no-carrier-added Lutetium-177 (n.c.a. Lu177), a medical radioisotope.
n.c.a. Lu177, a radiopharmaceutical precursor, is used in targeted Radionuclide therapy in the field of Precision Oncology.
Radiolabeled to disease specific targeting molecules, the tumor tissue is precisely destroyed. Isotopia has developed a GMP unique stable consistent and reliable method to produce a highly pure form of Lu177. n.c.a Lu177 contains no metastable Lu-177m, therefore there is no need for cost intensive clinical waste management.
Isotopia’s CEO, Dr. Eli Shalom stated “this is another achievement for Isotopia on its way to become a global leader in medical isotope’s production and supply. We have come a long way from a centralized nuclear pharmacy to a global GMP isotope manufacturer. Our mission in the near future is to install state-of-the-art production facility in the US and EU territories. These sites will be mass production for Pharma companies. beyond that, the next breakthrough into the global market is due to purchased FDA approved and EU certified aseptic pharmaceutical plant for theragnostic cold kits.”
The DMF filling is a necessary and significant step towards making a substantial contribution to meeting the growing demand of targeted Radionuclide Therapies within the U.S and Canadian markets. This will allow Isotopia to supply n.c.a. Lu177 to pharmaceutical companies developing new and innovative radiopharmaceuticals and take part in their clinical and commercial supply.
Isotopia will now focus on up-scaling production in the Israeli site and establishing another site to support the global supply and demand making sure that patients get treated anywhere and at any time.
The experienced Isotopia team, together with its radio-nuclear pharmacy, cyclotron facility, Lu177 production site and sterile manufacturing, are a well-established platform for development.