- SHINE Technologies plans to establish the largest non-carrier-added lutetium-177 production facility in North America by late 2023, following the recent opening of a similar facility in Germany.
- The facility will initially produce 100,000 doses of Lu-177 annually, with the potential to increase production to 200,000 doses in the future.
- SHINE aims to become the world’s first vertically integrated supplier of Lu-177 by producing its own ytterbium-176, the raw material for Lu-177 production, and is also developing a medical isotope production facility in Europe.
SHINE Technologies is set to establish the largest production facility for non-carrier-added lutetium-177 (Lu-177) in North America by the end of 2023. The company made the announcement on June 22, shortly after ITM Isotope Technologies Munich SE opened the world’s largest Lu-177 production facility in Germany.
Located at SHINE’s headquarters in Janesville, Wisconsin, the North American facility will initially manufacture 100,000 doses of Lu-177 annually, with the potential to scale up production to 200,000 doses in the future. Lu-177 is a low-energy beta particle emitter that, when combined with a targeting molecule, can precisely target and irradiate cancer cells while minimizing harm to healthy tissue. Two Lu-177-based radiotherapies, Lutetium Lu-177 dotatate (Lutathera) and 177Lu-PSMA-617 (Pluvicto), have already received FDA approval for treating endocrine tumors and prostate cancer, respectively, and more treatments are expected to be available commercially in the coming years.
Jess Giffey, the Chief Operating Officer of Systems and Therapeutics at SHINE, stated that the expansion of their production capabilities would help meet the urgent market demand for Lu-177 and ensure a reliable supply for their partners.
SHINE aims to become the world’s first vertically integrated supplier of Lu-177 by producing its own ytterbium-176, which is the raw material required for manufacturing Lu-177. Traditionally, Russia has been the sole supplier of ytterbium-176. Additionally, SHINE is developing a therapeutic medical isotope production facility in Europe with a production capacity similar to its U.S. facility.
Earlier this year, SHINE obtained approval from the U.S. Nuclear Regulatory Commission for the Operating License Application of its fusion-driven medical isotope production facility, known as The Chrysalis. The Chrysalis will serve as an irradiation source for Lu-177 production.
The installation of equipment at the Lu-177 production facility is expected to be completed in July, with licensing and validation runs already in progress.
