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RadioMedix and ITM greenlight Ge-68/Ga-68 generator production at new Texas facility

por John R. Fischer, Senior Reporter | July 30, 2018
Molecular Imaging PET
The new RadioMedix Spica Center is set to begin production of next-generation Germanium-68/Gallium-68 generators in a Texas facility, as outlined in an agreement between RadioMedix and Isotope Technologies Garching GmbH (ITG).

The Houston-based enterprise and subsidiary of Germany’s ITM Isotopen Technologien München (ITM) signaled for production to move forth at the CFR 211-compliant facility with the signing of a manufacturing and supply agreement aimed at reducing the shortage of such generators worldwide and providing greater access to targeted radionuclide therapy for cancer treatment.

“Our extended partnership with RadioMedix now gives us the opportunity to significantly improve our supply capabilities of our diagnostic radioisotope, Gallium-68,” Steffen Schuster, CEO of ITM, said in a statement. “This cooperation is an important further step, as it helps us secure the supply of high-quality medical radioisotopes for targeted radionuclide therapy to cancer patients worldwide.”
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Dedicated to late stage investigational and commercial stage radiopharmaceuticals, the facility is expected to support greater and more affordable access to Ge-68/Ga-68 generators across the country and potentially worldwide.

The production of Ge-68/Ga-68 generators falls in line with ITM’s objective to reduce the general shortage of radiopharmaceuticals all together, signified by its recent partnerships with Canada-based nuclear power player Bruce Power for the production of n.c.a. Lutetium-177 through 2064, and Indiana-based enterprise, Endocyte, for testing of the radiopharmaceutical for the treatment of advanced prostate cancer through 2035.

Supplied by ITM under the brand name, EndolucinBeta, n.c.a Lutetium-177 contains no metastable, long-lived Lutetium-177 impurities, an aspect that allows it to provide the highest specific activity of all forms of the Lutetium-177 radioisotope while ensuring greater environmental sustainability and more effective and economical waste management. In addition, it offers the best preconditions for the radiolabeling of biomolecules.

Just as with n.c.a. Lutetium-177, providers are using Ga-68 to diagnose conditions such as prostate cancer and neuroendocrine tumors more efficiently, producing PET images that map the location of specific cancers throughout the body.

“Ge-68/Ga-68 generators serve as an on-demand source of a positron emitter that has recently revolutionized the R&D and clinical developments in the field of PET radiopharmaceuticals,” Dr. Ebrahim S. Delpassand, chairman and CEO of RadioMedix, said in a statement. “The United States is one of the largest markets for these generators and a local manufacturing site, as well as a DMF at the U.S. FDA, for this product creates significant efficiencies in availability, cost, and distribution of this product in our country.”

RadioMedix did not respond for comment.

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