SHINE Technologies, LLC announces submission of FDA Drug Master File for non-carrier-added lutetium-177

Press releases may be edited for formatting or style | April 08, 2024 Molecular Imaging
JANESVILLE, Wis., April 8, 2024 /PRNewswire/ -- SHINE Technologies, LLC (SHINE), a pioneer in next-generation fusion-based technology, becomes North America's largest producer of non-carrier added lutetium-177 (n.c.a. Lu-177) chloride, a cutting-edge radiopharmaceutical used in precision cancer treatment, with a Drug Master File (DMF) to the U.S. Food and Drug Administration.

In targeted cancer therapy, the cancer-killing radioisotope Lu-177 is paired with a cancer-seeking molecule to form a smart compound that directly targets and attacks cancer cells. Lu-177 is especially useful for treating prostate cancer, one of the most common forms of cancer.

Leveraging proprietary technology processes to ensure a reliable and scalable supply of Lu-177, SHINE is at the forefront of medical radioisotope production used in radiopharmaceutical cancer therapy, which is one of the fastest-growing markets in oncology.
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The DMF submission provides confidential, detailed information about SHINE's facilities, procedures, and articles utilized in drug manufacturing, processing, and storage. With this launch, SHINE demonstrates its dedication to collaborating with companies pursuing clinical trials to combat cancer and its profitability as a company.

"Our rapid progress in delivering Cassiopeia, a first-of-its-kind facility, equipped with the most innovative and efficient technology in the industry demonstrates the value our team can bring as demand for new radioisotope-based cancer therapies scale," said Greg Piefer, founder and CEO of SHINE Technologies. "It's especially important to have domestic production in the U.S., which is the largest market for cancer therapy in the world, and I believe we're the first to operate here at scale. The DMF means we're on the fast track to deliver for our customers, reducing U.S. dependency on foreign sources while also enhancing global supply chains for critical medical radioisotopes. Further, this milestone marks a significant step forward in our long-term vision to create a safer, healthier and cleaner world using advanced nuclear technology."

Lu-177 will be produced exclusively in SHINE's Cassiopeia facility in Janesville, Wisconsin. This facility is the largest of its kind in North America and will boast an initial production capacity of 100,000 doses per year, with the potential for expansion to 200,000 doses annually. By producing Lu-177 in North America, SHINE reduces transit times companies currently experience and diminishes the possibility of Lu-177's decay. This momentum follows SHINE achieving cold and hot commissioning in under 12 months, showcasing its commitment to utilizing cutting-edge technology for rapid progress.

Looking ahead, SHINE aims to become the world's first vertically integrated Lu-177 supplier. Besides the ability to produce ytterbium-176 internally, SHINE plans to leverage its fusion-driven medical isotope production facility, The Chrysalis, as an irradiation source for n.c.a. Lu-177 production, in addition to its longstanding plan to produce molybdenum-99.

SHINE's advancements in Lu-177 production represent a significant leap forward in the fight against cancer, offering hope to patients worldwide.

About SHINE Technologies
Headquartered in Janesville, Wisconsin, SHINE Technologies stands as an industry leader in next-generation fusion, deploying innovative fusion and fusion-based technology that seamlessly combines safety, cost-efficiency, and environmental responsibility. SHINE is at the forefront of creating non-carrier-added lutetium-177 – a vital component in cutting-edge medical treatments.

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