SHINE Technologies Submits Drug Master File with the U.S. Food and Drug Administration for Non-Carrier-Added Lutetium-177 Chloride
JANESVILLE, Wis., July 27 – SHINE Technologies, LLC (SHINE), a next-generation nuclear technology company, today announced the company has submitted a Drug Master File (DMF) with the U.S. Food and Drug Administration for non-carrier-added 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 paired with a cancer-seeking 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 industry’s 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 articles used in the manufacturing, processing, and storing of drugs. It is a clear commitment to the several companies that have requested letters of authorization to access SHINE’s drug master file in support of their clinical trials which are underway to fight cancer. And it is also an important step in SHINE’s path to meeting the increasing global demand for Lu-177.
“As global demand for lutetium-177 increases, SHINE is poised to scale our operations and be the preferred partner for customers seeking a high-quality, reliable supply of lutetium-177,” said Chris Vessell, general manager of SHINE’s Therapeutics Division.
“We’ve been producing lutetium-177 that meets or exceeds customer specifications for some time now, and the DMF submittal represents the next step in getting our product into regular commercial use.” said Greg Piefer, founder and CEO of SHINE Technologies. “We’re looking forward to growing our vertically-integrated and sustainable process to ensure the world has scalable access to these game-changing, cancer-destroying products as new therapies are approved.”