SHINE Technologies has announced that it will open the largest production facility in North America for non-carrier-added lutetium-177 in late 2023.

The announcement was made on June 22, coming days after ITM Isotope Technologies Munich SE opened the largest Lu-177 production facility in the world in Germany.

The North American facility, which will be located at SHINE’s headquarters in Janesville, Wisconsin, will initially produce 100,000 doses of Lu-177 annually, and have the capacity to scale production to 200,000 in the future.
Lu-177 is a low-energy beta particle emitter that, when paired with a targeting molecule, precisely targets and irradiates cancer cells, while reducing damage to healthy tissue. Two Lu-177 based radiotherapies, Lutetium Lu-177 dotatate (Lutathera) and 177Lu-PSMA-617 (Pluvicto), are FDA approved for treating endocrine tumors and prostate cancer, respectively, with more expected to be commercially released in the coming years.

“Scaling up our production capabilities will help our partners secure their supply, and fill the urgent market demand,” said Jess Giffey, SHINE’s COO of Systems and Therapeutics, in a statement.

SHINE plans to become the world’s first vertically integrated supplier of Lu-177, and is producing its own ytterbium-176, the raw material for making Lu-177, which has historically been supplied solely by Russia. It also is designing a therapeutic medical isotope production facility in Europe with similar production capacity as its U.S. facility.

Earlier this year, the company received approval from the U.S. Nuclear Regulatory Commission for the Operating License Application of its fusion-driven medical isotope production facility, The Chrysalis, which will be an irradiation source for Lu-177 production.

Equipment installation at the Lu-177 production facility is expected to finish in July, and licensing and validation runs are underway.

Business Affairs Homepage