SHINE Medical Technologies on Thursday received federal approval to build its $100 million radioisotope production facility in Janesville, Wis., with operations expected to begin in 2019.
In a unanimous decision this week, the four-member Nuclear Regulatory Commission authorized the issuance of the construction permit, which SHINE has been pursuing for four years, two of which was spent in environmental and safety review.
This puts SHINE well ahead of two other companies in the race to become the first American commercial producer of molybdenum-99, a medical isotope used in imaging procedures for cancer, heart disease, and bone and kidney disease. The Western Hemisphere will be without a supplier of moly-99 in March 2018, when Canada’s National Research Universal reactor is scheduled to shut down.
Northwest Medical Isotopes intends to build a $50 million facility at Discovery Ridge research park in Columbia, Mo., with plans to submit a license application this year. Coqui RadioPharmaceuticals Corp. plans to submit its own application to the NRC in 2017 for a $330 million facility in Alachua, Fla. Coqui hopes to begin production in late 2020 or early 2021.
For fiscal 2016 and 2017, NRC has budgeted $3.1 million and $3.7 million, respectively, for medical isotope production license reviews.
Katrina Pitas, SHINE’s vice president of business development, regarded Thursday “as a really big day” for the company.
“Everyone is thrilled,” Pitas said in a telephone interview. “There was cheering (around the office), high-fiving, hugging, a few people in tears. … We’re looking forward to supplying the U.S. with the medical isotopes the patients need.”
She said the project is on schedule, and the company plans to break ground on the 57,000-square-foot facility in 2017 and produce test batches in 2018.
“This is the first time in over fifty years a medical isotope plant of this kind has been granted a construction permit,” SHINE CEO Greg Piefer said in a press release. “We’ve developed a greener, safer, and cheaper way to produce these life-saving isotopes on a global scale. Once operational we expect the Janesville facility will improve the lives of over 1 billion people over its lifetime. It’s a very exciting time at SHINE.”
In January, SHINE said it had raised about half the funding needed for the $100 million facility, which includes both private and public contributions. The National Nuclear Security Administration, a semiautonomous Department of Energy agency, has awarded more than $25 million to the project. The funding was sourced through the Global Threat Reduction Initiative, a program intended to increase domestic supply of the isotope and minimize civilian use of highly enriched uranium.
Before it can begin operation, SHINE must submit a separate operating license application for NRC approval. That application will include a final safety analysis report for SHINE’s facility design, plans for operation, emergency plan, physical security plan, and technical specifications. SHINE expects to submit that application in 2017, and NRC anticipated an 18 to 24 month turnaround.
Coqui Hopes to Start Radioisotope Plant Licensing in 2017
Meanwhile, Coqui RadioPharmaceuticals plans to submit the construction and licensing application for its facility to the NRC in 2017, a project representative said Tuesday.
Coqui has partnered with Argentinian nuclear engineering firm INVAP and Nashville-based architectural, engineering, and environmental firm Gresham, Smith and Partners. Kevin Tilbury, a planner with the Nashville firm, said by email that Coqui expects to begin construction on the 250,000-square-foot facility in 2018 and begin operations within three years afterward. In 2015, the team announced the completion of its schematic design, with plans for submitting its NRC license application by the end of 2015.
