US firms target revival in domestic Mo-99 production

01 May 2015

The leaders of two rival projects to produce molybdenum-99 (Mo-99) commercially in the USA are united in their goal to reinvigorate the country's domestic supply of the lifesaving radioisotope.

Mo-99 is the precursor of technetium-99m (Tc-99m), the most widely used isotope in nuclear medicine. Mo-99 has a half-life of only 66 hours, meaning that supplies need to be constantly replenished. Canada's National Research Universal reactor (NRU), built at Chalk River in 1957, produces 40% of world supply of Mo-99. It is due to be shut down in March 2018.

Coquí RadioPharmaceuticals Corp announced last month that it had completed the schematic design of its $330 million medical isotope production facility to be built in Alachua, Florida. Coquí Pharma will soon enter the detailed design phase as it readies to submit its construction licence application to the Nuclear Regulatory Commission by the end of this year.

In February, a Canadian-US partnership was announced to create a "new, reliable supply" of medical isotopes for use worldwide. Canada's Nordion and its US parent company Sterigenics International signed partnership agreements with the USA's General Atomics (GA) and the University of Missouri Research Reactor Center (MURR). Through the agreements, sterilization specialist Sterigenics and radioisotope supplier Nordion will be supplied with Mo-99 produced in MURR's research reactor using targets incorporating low-enriched uranium supplied by GA.

Coquí Pharma President and CEO Carmen Bigles told World Nuclear News the company has designed the capacity of its facility "to reliably produce at a commercial scale 7000 six-day curies of Mo-99 with proven technology". The Puerto Rican company, based in Coral Gables, aims to become the first US commercial supplier of Mo-99, which is used in 20 million medical procedures each year in the USA.

"NRU in Canada has the capacity to produce approximately 7000 six-day curies at a commercial scale. When this shuts down it will be a significant blow to the reliability of world supply and more so to the western hemisphere since there is no significant commercial producer on this side of the globe for a product that only lasts 66 hours," Bigles said.

"For me, creating Coquí Pharma is a very important mission. I noticed that patients were coming to Caribbean Radiation Oncology Center - of which I am the co-founder - without the needed diagnosis for treatment and learned this was because of a shortage of Mo-99. The impending global shortage of medical isotopes is a real threat and we are facing a delay in life-saving treatments, diagnosis and research because of it."

New beginnings

Nordion's medical isotope president, Tom Burnett, told World Nuclear News that the three partners involved in its project expect to start commercial production by late-2017.

Canadian life sciences company MDS Nordion (now Nordion) contracted Atomic Energy of Canada Ltd (AECL) to build two research reactors in 1996 under an agreement known as the Isotope Production Facilities Agreement. AECL announced in May 2008 that it had decided to immediately discontinue development work of the two MAPLE research reactors at its Chalk River Laboratories in Ontario. MDS Nordion launched legal proceedings against AECL and they reached a settlement in August 2013.

The MAPLE (Multipurpose Applied Physics Lattice Experiment) design is a pool-type reactor with a compact core of low-enriched uranium fuel surrounded by a vessel of heavy water. The two MAPLE units were to be the world's first reactors dedicated exclusively to medical isotope production. Once completed, the reactors could have supplied the entire global demand for Mo-99, iodine-131, iodine-125 and xenon-133. At any one time, one MAPLE reactor was to be the primary isotope producer while the other reactor would be available for full back-up. The first two 10 MW MAPLE units were undergoing commissioning at Chalk River. The reactors were originally scheduled to start up in 2000. One unit went critical in 2000, the second in 2003, but commissioning encountered major technical problems.

Burnett said the new project will produce medical isotopes using selective gaseous extraction technology with low-enriched uranium targets, rather than highly-enriched uranium (HEU) targets. The MAPLE project used HEU targets. The new project will also use an existing and proven reactor (MURR), while the MAPLE project involved the design and construction of two new reactors.

Bigles said she feared that the use of the emergent technology, selective gaseous extraction, "may be a repeat of the Babcock &Wilcox/Covidien proposal which was also emergent technology and was later abandoned".

In October 2012, Covidien and Babcock & Wilcox Technical Services Group announced that they were discontinuing their joint venture towards the development of solutions-based reactor technology for medical isotope production. This decision was reached after learning that the time and cost involved with the project would be greater than originally expected.

On the new Canadian-US partnership, Bigles said: "For the benefit of patients, I hope it works in time, and in that respect we don't see them as a rival but as partners in this effort to secure a domestic supply of Mo-99."

Burnett noted that the science behind the MAPLE reactors and Nordion's current project "are different and can't be compared".

"We brought Mo-99 on to the market 40 years ago, so we understand it better than anyone else in terms of bringing it to commercial fruition," Burnett said. "The trilateral partnership will create the best and most reliable commercial supply of medical isotopes with routine supply expected in 2017 for the global health community, during a period when other nuclear reactors are being decommissioned or shut down for maintenance."

He added: "Nordion welcomes the efforts of government and private sector consortiums across North America and around the world which are working towards securing a reliable supply of medical isotopes for commercial production."

Government objective

The Department of Energy's National Nuclear Security Administration (NNSA) has said that, because the USA currently imports the majority of its Mo-99 supply from subsidized, aging facilities abroad, most of which is produced with HEU, it aims to ensure that this important medical isotope is readily available to meet patient needs, and produced in accordance with US nuclear non-proliferation policy.

Since 2009, it has partnered with US commercial entities to accelerate the development of a diverse set of non-HEU technologies to produce Mo-99 in the USA. Its current commercial partners include: NorthStar Medical Radioisotopes, which is developing both neutron capture and accelerator-based technologies that will utilize NorthStar's RadioGenixTM Tc-99m Generating System; and SHINE Medical Technologies, which is developing accelerator technology with LEU fission.

NNSA's cooperative agreements are implemented under a 50%-50% cost-share arrangement. Its support to the total project cost of the cooperative agreement partners is up to $25 million each, consistent with policy guidelines from the Organization of Economic Cooperation and Development - Nuclear Energy Agency.

On its website, NNSA lists Coquí RadioPharmaceuticals Corp, Eden Radioisotopes, Flibe Energy, Niowave, Northwest Medical Isotopes, NuView and PermaFix as some of the other organizations in the USA that are also working to develop the ability to produce non-HEU-based Mo-99. "While independent of NNSA's Mo-99 Program, these projects are complementary to domestic and international efforts to ensure a reliable supply of Mo-99 produced without HEU," it says.

Researched and written
by World Nuclear News