SHINE Technologies Submits Drug Master File to U.S. Food and Drug Administration for Lutetium-177 Chloride Without Added Carrier
JANESVILLE, Wis., July 29, 2022 /PRNewswire/ — SHINE Technologies, LLC (SHINE), a next-generation nuclear technology company, today announced that the company has submitted a Drug Master File (DMF) to the United States Food and Drug Administration. for carrier-free lutetium-177 (Lu-177) chloride, a radiopharmaceutical at the forefront of precision cancer treatment.
In targeted cancer therapy, the cancer-killing radioisotope Lu-177 is combined with an anticancer molecule to form a smart compound that directly targets and attacks cancer cells.
SHINE is the emerging leader in the production of this medical radioisotope. With its proprietary technology, SHINE intends to be the only vertically integrated producer of Lu-177, providing a reliable and scalable supply without the need for aging nuclear reactors.
The DMF submission provides confidential detailed information about facilities, procedures, or items used in the manufacture, processing, and storage of drugs. This is a clear commitment to the many companies that have requested clearance letters to access SHINE’s drug master file in support of their ongoing clinical trials to fight cancer. And it’s also an important step in SHINE’s path to meet the growing global demand for Lu-177.
“As global demand for Lutetium-177 increases, SHINE is poised to expand operations and be the preferred partner for customers seeking a reliable, high-quality supply of Lutetium-177,” said declared Chris VesselManaging Director of SHINE’s Therapeutic Division.
“We have been producing Lutetium-177 that meets or exceeds customer specifications for some time now, and the DMF submission represents the next step in the regular commercial use of our product.” said Greg Piefer, founder and CEO of SHINE Technologies. “We look forward to growing our vertically integrated and sustainable process to ensure the world has scalable access to these game-changing, cancer-fighting products as new therapies are approved.
SHINE is a next-generation nuclear technology company, deploying cutting-edge fusion technology to create an evolutionary path to fusion energy. Based in the south Wisconsinwhose head office is at Janesvilleand with a future site under development at Europe, SHINE deploys its safe, cost-effective and environmentally friendly technology in a phased approach. Our systems are used for industrial component imaging in the aerospace, defense, transportation, energy and other industries. And SHINE’s proprietary isotope production processes create unsupported molybdenum-99 and lutetium-177 used in tens of thousands of daily procedures to diagnose and treat heart disease and advanced cancers. For more information, follow SHINE on Facebook, LinkedIn and Twitter.
SOURCE SHINE Technologies, LLC