NorthStar Medical Radioisotopes said Wednesday it is upgrading its production operations at the University of Missouri Research Reactor (MURR), adding a new high-capacity filling line the company says will ultimately quadruple its dispensing capacity for the medical radioisotope molybendum-99.
Moly-99 is used in imaging procedures for cancer, heart disease, and bone and kidney disease. The Western Hemisphere is expected to be without a moly-99 supplier starting in March 2018, when Canada plans to shut down its National Research Universal reactor.
NorthStar has partnered with Von Gahlen International to design and install the dispensing system, which Wednesday’s announcement says will include “a high-capacity DPharm unit to fill source vessels quickly, along with companion nuclear radiation containment chambers, or ‘hot cells.’” NorthStar is investing more than $3 million in new development processes for producing moly-99 without the use of highly enriched uranium. Production is expected to begin in the first half of 2017. MURR will deliver the stock solution for the isotope, and NorthStar’s DPharm unit will dispense it into a vial inside a lead shield, which will be shipped to customers.
“This increased capacity will enable us to meet the anticipated demand for our non-HEU Mo-99 and our RadioGeni isotope separation system,” NorthStar Chairman, President, and CEO George Messina said in a statement. “Our recent progress toward commercialization of our production processes, and the encouraging feedback we’ve received from the marketplace, justify this investment. We are confident it will pay dividends for years to come.”
SHINE Medical Technologies, Northwest Medical Isotopes, and Coqui RadioPharmaceuticals Corp. are also vying to be the first American commercial producers of moly-99 in more than 25 years. Northwest aims to start production in 2018, SHINE in 2019, and Coqui in 2020-21. While SHINE, Northwest, and Coqui require construction and operating approval from the Nuclear Regulatory Commission, MURR already has an NRC license to operate. NorthStar, though, is waiting for is Federal Drug Administration approval for the product, with no definitive timeline.
“I think we continue to gain momentum towards commercialization,” NorthStar Vice President for Business Development Ed Fennell said in a telephone interview Thursday. “We fully expect to be the first U.S.-based commercial supplier of molybendum-99 since 1989. We’ll be the first to market in the United States.”
SHINE Medical Technologies founder and CEO Greg Piefer told RadWaste Monitor recently that his company’s goal is to secure 100 percent funding by the end of the year for its estimated $100 million radioisotope production facility in Janesville, Wis. SHINE so far has raised $50 million, which includes $11.5 million in private funding. SHINE has been awarded an up to $25 million federal grant through a National Nuclear Security Administration nonproliferation program. The grant is awarded on a cost-share basis, so SHINE will have to match the federal government’s amount.
Northwest Medical Isotopes intends to build a $70 million, privately funded facility at the Discovery Ridge research park in Columbia, Mo. COO and Vice President Carolyn Haass said in a recent interview that the company has submitted its construction application to the NRC, plans to turn in its operating license application in early 2017, and to begin commercial operation in late 2018.
Coqui RadioPharmaceuticals hopes to begin production at its $400 million facility in Alachua, Fla., in late 2020 or early 2021. President and CEO Carmen Bigles said that while financing has held the project back, Coqui has achieved 60 percent completion on the design of its facility.
