Shine Technologies, LLC, a next-generation fusion technology company, opened the largest facility in North America dedicated to the production of non-carrier-added lutetium-177, a medical isotope used in targeted cancer therapies.

The new facility, which will operate at Shine’s headquarters in Janesville, WI, is expected to have an initial production capacity of 100,000 doses of Lu-177 per year, with the ability to further expand production capacity to 200,000 doses per year in the future.

Lu-177 is a radioactive agent that, when paired with a cancer-seeking molecule, delivers highly targeted radiation to cancer metastases, killing cancer cells while minimizing damage to surrounding healthy cells. There are currently two Lu-177-based radiotherapies that have been commercially approved, and the market is expected to continue its rapid growth with advancements across new therapies and indications in clinical trials.

Installation of equipment in the new facility is ongoing and slated to be finished in July. Following the completion of licensing and validation runs, Shine expects to have product available for commercial use from its new facility in late 2023. 

In addition, Shine has initiated design and licensing processes for a dedicated therapeutic medical isotope production facility in Europe. Shine expects its European facility to have a similar production capacity to its U.S. facility, further bolstering its ability to meet customer needs and service the growing Lu-177 market.

In a prepared statement, the company said that it aims to become the first vertically integrated supplier of Lu-177 in the world. Along with producing its own ytterbium-176, the company plans to be able to utilize its fusion-driven medical isotope production facility, The Chrysalis, as its irradiation source for the production of Lu-177. The Nuclear Regulatory Commission issued its Final Safety Evaluation Report related to the Operating License Application for that facility earlier this year.

“At Shine we innovate to serve markets where there is a nexus of unmet demand, challenges where our unique capabilities will drive value, and positive impact on the world. We’re at that intersection with our therapeutics business, currently focused on delivering lutetium-177 at the largest scale in the U.S.,” said Greg Piefer, founder, and CEO of Shine. “Advancements in radiopharmaceutical therapies have shown great results in extending the lives of patients who might otherwise be out of options, and earlier therapy appears even more promising. We’re excited to play an important role in making sure these groundbreaking therapies reach patients faster, potentially saving or extending the lives of many tens of thousands of people each year.”