Janesville-based SHINE Technologies, a manufacturer of medical isotopes, has opened the largest production facility dedicated to producing Lutetium-177 in North America.
SHINE first began manufacturing Lutetium-177, also called Lu-177, in April 2021. The company said it saw strong demand for Lu-177 from clinical trial sponsors because of its potential to revolutionize the treatment of cancer patients.
Lu-177 will be used by Australia-based biotech company Radiopharm Theranostics in the development of its clinical pipeline of diagnostic and therapeutic radiopharmaceutical products. Lu-177 is an important isotope utilized in multiple programs across Radiopharm’s portfolio.
SHINE’s new 18,700-square-foot facility is located at the company’s Janesville headquarters. It’s 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.
“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 chief executive officer 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.”
Installation of equipment in the new facility is ongoing and scheduled to be finished next month. Following the completion of licensing and validation runs, SHINE expects to have product available for commercial use from its new facility in late 2023.
Moving forward, SHINE plans to become the first vertically integrated supplier of Lu-177 in the world.