Jeremy L. Dillon
RW Monitor
09/4/2015
Perma-Fix Medical S.A. said on Monday it has achieved a six curies radiation level for its technetium-99m production. Earlier this year, Perma-Fix said it needed to reconfigure its production process after realizing that market demand for the medical isotope used in millions of procedures annually called for a larger design. The latest milestone confirms Perma-Fix’s proprietary resin could withstand higher levels of radiation while still producing usable doses of Tc-99m.
“Achieving these results at the 6 curie level are extremely gratifying and further reinforce what we had expected,”Perma-Fix CEO Stephen Belcher said in a statement. “We plan to conduct additional tests in the near future; but based on these preliminary results, we are extremely confident in our path forward. Importantly, we believe we are now in a position to meet the requirements of customers, not only in emerging markets, but also in North American and European markets.”
Perma-Fix is one of several companies vying for position in the market for technetium-99m. With Canada set to stop government spending in 2016 on the National Research Universal (NRU) reactor, one of the world’s largest suppliers of molybdenum-99 and technetium-99m, the medical isotope industry anticipates a shortage in the market in the coming years. NRU’s anticipated shutdown has led to a slew of start-ups looking to fill the lucrative medical isotope void—eight-to-nine companies have already sent the Nuclear Regulatory Commission letters of intent to submit construction authorization licenses for a potential Mo-99 production facility.
NorthStar Ramps Up Production Process
Meanwhile, NorthStar Medical Radioisotopes announced this week that it has received approval from the University of Missouri Research Reactor to begin routine production of molybdenum-99 at the MURR facility, enabling the company to establish a weekly production schedule and increase its output. The milestone will help NorthStar transition from development to a routine production process in order to boost its output at MURR to as much as 200 6-day curies per process, the company said. Once NorthStar submits its final regulatory amendment to the Food and Drug Administration – anticipated by the end of the year – the company expects ultimately to produce up to 3,000 6-day Ci at MURR.
“Approval to routinely operate our aliquoting line is a major milestone toward becoming the first commercial producer of Mo-99 in the United States in more than 25 years and giving health care professionals nationwide reliable access to the Tc-99m they need to provide patients accurate diagnoses and conduct important research,” said James Harvey, NorthStar senior vice president and chief science officer, in a statement.
NorthStar is developing two technologies for producing Mo-99 without the use of highly enriched uranium, including a neutron capture process using the MURR facility and an electron accelerator process. The United States, through the National Nuclear Security Administration, has instituted a cost-sharing agreement with NorthStar and SHINE Medical Technologies to help jump-start domestic production of Mo-99. Both companies expect to begin production sometime near the end of 2016 or in early 2017, depending on how quickly they can navigate the regulatory process.
