SHINE Medical Technologies, a Monona, Wisconsin-based medical isotope manufacturer founded in 2010, announced back in October 2015 that the Nuclear Regulatory Commission (NRC) had recommended approval of its construction permit for a new production facility in Janesville, Wisconsin. The facility is being built for the production of molybdenum-99 (Mo-99) without highly enriched uranium.
Katrina Pitas, vice president of business development for SHINE, is in St. Louis this week to speak at the 2016 Mo-99 Topical Meeting. While preparing for her presentation, Pitas took time to speak with Health Imaging about what SHINE has been up to this year and what she will be discussing at the meeting.
Health Imaging: In 2015, the U.S. Department of Energy’s National Nuclear Security Administration (NNSA) gave $1 million to SHINE to assist the company with perfecting its process of producing Mo-99. Can you touch on what it meant to get that support from the U.S. government?
Katrina Pitas: The ongoing support of the NNSA—$15 million to date—has been an incredibly important accelerant to the project, both financially and technically. Their assistance has certainly contributed to our success so far, and the on-going partnership will help ensure the timely startup of our production facility—a national asset that will provide life-saving materials for a billion people over its lifetime.
Can you describe SHINE Medical Technologies’ method for producing Mo-99?
SHINE has a new technology for producing Mo-99 that has major advantages over the traditional, reactor-based method. We use a proprietary, low-energy accelerator technology to produce neutrons via fusion reactions. Then we use those neutrons to create the Mo-99 from low-enriched uranium in an aqueous solution.
The biggest advantage of this approach is dramatically increased production efficiency. In the SHINE process, every uranium atom that reacts can produce usable Mo-99. In a reactor, the majority of the uranium being used is in the reactor’s core, and the Mo-99 produced there can’t be extracted for medical use. This difference alone results in hundreds of times less radioactivity produced per useful isotope with the SHINE process.
Another important aspect of our method is that there is no highly-enriched or “bomb-grade” uranium anywhere in the process.
Last November, we proved that Mo-99 produced by the SHINE process is equivalent to reactor-based Mo-99—Argonne National Laboratory produced Mo-99 using SHINE’s process and GE Healthcare loaded the Mo-99 on one of its Tc-99m generators. The Tc-99m eluted from the generator met all of GE’s quality specifications and successfully labeled both Myoview and Ceretec. This is the first time a demonstration like this has ever been done with non-reactor-based Mo-99.
What has the company been up to since receiving approval from the NRC to begin construction on its radioisotope production facility in Wisconsin?
We’ve been busy! In March, we demonstrated 97 percent accelerator uptime over 132 consecutive hours. That’s five and a half days straight and equivalent to how the accelerator will need to run the in production facility. We’ve hired our VP of Project Delivery and selected the outside contractor team to complete design and construction of the facility. In June, we entered into a strategic agreement to supply HTA with Mo-99 once the facility is up and running. HTA is our third signed customer, following GE Healthcare and Lantheus Medical Imaging, and is the largest distributor of medical isotopes in China.
Can you tell me a bit about the upcoming 2016 DOE/NNSA Mo-99 Topical Meeting? What do you have planned for your presentation?
This will be the fifth Mo-99 Topical Meeting since the first one was held in Santa Fe back in 2011. The meeting is intended to serve as a workshop where policy and technical experts can gather to present and discuss progress toward achieving a reliable, global supply of Mo-99 produced without the use of proliferation-sensitive highly-enriched uranium. My presentation will provide a brief introduction to SHINE for anyone in the audience who is new to the meeting, and then provide an update on SHINE’s progress since last year’s meeting, starting with the issuance of our Construction Permit by the Nuclear Regulatory Commission in February.
What’s next for SHINE Medical Technologies?
SHINE has a very exciting future ahead of it—in the next year we’ll break ground on our production facility and start ramping up staffing for the facility. We’ll begin commercial production in 2019, and by the end of 2020, we’ll be the worldwide leader in the safe, clean, affordable production of medical isotopes. While we have a number of additional long-term opportunities, today we’re laser-focused on commercialization of Mo-99.
This text was edited for clarity and space.