SHINE signed a definitive agreement providing a $150 million financing commitment with Deerfield Management Company, a healthcare investment firm. Deerfield’s investment will be used for the construction of SHINE’s main production facility. The investment is tranched, based on SHINE achieving milestones.
Phoenix delivered the first production accelerator to SHINE’s Building One, the first building on the SHINE medical isotope production campus. Known as the first production unit, this state-of-the-art accelerator system was designed and built by Phoenix specifically for the SHINE medical isotope project, which will produce radioisotopes used in medical imaging. Previous Phoenix prototype systems demonstrated the neutron output and up-time required for medical isotope production in the SHINE facility. The first production unit is the third-generation design for SHINE and is the first system designed for regular commercial use. “This delivery represents the culmination of almost a decade of joint work between Phoenix and SHINE, moving from proof of concept, to proof of scale, and now to a commercial-ready unit that can produce thousands of doses of medicine per day when paired with the SHINE target. Our tests in Building One will prove the technology is ready for production and provide us important maintenance and operational data well in advance of starting up the actual plant, “ said SHINE CEO, Greg Piefer.
After breaking ground in August of 2017, JP Cullen completed the 6-month construction project three weeks ahead of schedule and on budget, with zero OSHA-recordable incidents. During construction of SHINE’s main production facility, Building One will be used to train employees and develop operating history with equipment. Going forward, Building One will be a state-of-the-art technology development center.
The first building to be built for the SHINE campus, Building One will be one of the most advanced, private, nuclear technology facilities in the world. The facility will initially be used to house the first fully integrated, full-size SHINE production system. During construction of SHINE’s main production facility, Building One will be used to train employees and develop an operating history with equipment. Going forward, Building One will be a state-of-the-art technology development center. “Building One’s name was chosen because it’s intended to be a technological genesis building,” said Greg Piefer, founder, and CEO of SHINE. “It’s intended to be a laboratory in which we’re going to continue to develop new technologies to keep SHINE at the forefront of not just medical isotope production, but to go beyond that.”
SHINE held a ribbon cutting ceremony to celebrate the grand opening of its new global headquarters in downtown Janesville, Wisconsin. The ribbon cutting was led by the Forward Janesville Goodwill Ambassadors. SHINE employees were joined at the celebration by neighbors and Janesville community members. In honor of the Martin Luther King, Jr. Day of Service, guests of the ceremony were asked to bring a non-perishable food item to benefit ECHO (Everyone Cooperating to Help Others). A full barrel of donations was collected for the local food pantry. At the time, SHINE had approximately 35 occupying the top floor of the Prospect 101 building at 101 E. Milwaukee Street. The building is approximately 6 miles north of the future production facility, which will be built near the Southern Wisconsin Regional Airport. SHINE selected Janesville for the location of its production facility after an extensive site selection process in 2012.
SHINE signed a supply agreement with HTA Co., Ltd. (HTA), the largest Chinese producer and distributor of radio-pharmaceuticals. The supply agreement marked HTA’s first with a U.S. supplier of moly-99. Under the terms of the agreement, SHINE will provide moly‑99 produced using its proprietary low enriched uranium (LEU)-solution technology for use in HTA’s technetium generators once SHINE’s facility becomes operational. SHINE’s LEU moly-99 manufacturing process does not require a nuclear reactor and is compatible with the world’s existing supply chain for moly-99. “HTA, the largest distributor of medical isotopes in China, is a great company, playing a critical role in patient care, and we believe this is the beginning of a long, successful relationship between HTA and SHINE,” said Mr. Guo Chunsheng, President of HTA, about the agreement.
SHINE and Phoenix Nuclear (PNL) successfully operated their accelerator-based neutron generator for 132 consecutive hours with greater than 97% uptime. This accomplishment represented an industry first for the extended-operation reliability of a gas target neutron generator and was an important demonstration of the robustness of the PNL neutron generator, a key enabling technology for the SHINE medical isotope production facility. PNL manufactures the world’s strongest neutron generators and was selected by SHINE to provide the neutron generators for SHINE’s eight medical isotope production units. To achieve high medical isotope yields, the PNL neutron generators must run for approximately 132-hour cycles in order to ensure patients receive critically important doses on time. “The PNL team has once again demonstrated that their accelerator technology is far superior to anything else on the market,” said Todd Asmuth, President of SHINE.
In 2016, the U.S. Nuclear Regulatory Commission (NRC) issued the SHINE construction permit. SHINE is the only U.S. medical isotope producer to have reached this stage of the NRC permitting process since the 1960s. The issuance of the construction permit was the culmination of more than four years of effort by both SHINE and the NRC. It follows two years of environmental data collection and safety analysis by SHINE, as well as two years of rigorous safety and environmental reviews by the NRC. With the construction permit in hand, SHINE has federal regulatory approval to begin construction of its approximately 57,000 ft² medical isotope manufacturing facility in Janesville, WI. It was the first time in over fifty years a medical isotope plant of this kind was granted a construction permit.
SHINE and GE Healthcare announced they successfully obtained pharmaceutical-grade Tc-99m from GE Healthcare’s DRYTEC™ generator using Mo-99 produced by SHINE’s innovative process. The positive results of this test confirm that Mo-99 produced by the SHINE process can be incorporated into the existing Mo-99 supply chain. Use of SHINE-produced Mo-99 in DRYTEC™ Tc-99m generators will not require changes to radiopharmacy practices or how the resulting Tc-99m is used in scanning procedures. After successfully producing Tc-99m in the DRYTEC™ generator using SHINE Mo-99, GE tested it in the preparation of finished radiopharmaceuticals using kits of GE Healthcare Tc-99m-based products: Myoview™ and Ceretec™. Successful quality control testing was performed on the reconstituted kits, indicating feasibility for Tc-99m radiopharmaceuticals prepared using this material.
Argonne National Laboratory (Argonne) successfully demonstrated the production, separation, and purification of molybdenum-99 (Mo-99) from SHINE’s innovative liquid target. The resulting Mo-99 product purity was equivalent to the Mo-99 used in the supply chain today. The demonstration—known as Mini-SHINE— uses the same process flows that will be used in the SHINE manufacturing facility and further validates SHINE’s technical approach. Earlier tests performed by Los Alamos National Laboratory found near-complete recovery of the Mo-99 from SHINE’s liquid target, and that this yield did not change when the target solution was recycled. Argonne took testing of the liquid target a step further by building a tip-to-tail pilot demonstration. The Mini-SHINE test validates every step of the production chemistry: from plant – relevant irradiation conditions through purification of the Mo-99 to current industry standards. The work was supported by the Department of Energy’s National Nuclear Security Administration’s Mo-99 Program.
Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents, and SHINE entered into a strategic agreement for the future supply of molybdenum-99 (Mo-99). The supply agreement marked Lantheus’ first with a prospective U.S. supplier of Mo-99. Under the terms of the supply agreement, SHINE will provide Mo-99 produced using its proprietary low enriched uranium (LEU)-solution technology for use in Lantheus’ TechneLite® generators once SHINE’s facility becomes operational. This definitive agreement with Lantheus signals the beginning of a new era for the production of radioisotopes in North America, in which a private producer can thrive. This agreement, along with another agreement earlier this year, show that SHINE is important to the future of medical isotope generation,” said Greg Piefer, founder and Chief Executive Officer of SHINE.
SHINE entered into a strategic long‐term supply agreement with GE Healthcare, a division of the General Electric Company, for the supply of molybdenum‐99 (moly‐99). This is the first announcement of a major supply agreement with a U.S. based producer of moly‐99. Under the terms of the supply agreement, SHINE will provide moly‐99 to GE Healthcare on a regular basis once its facility becomes operational. “GE Healthcare is very pleased to have entered into a long‐term supply agreement with SHINE. The technology represents a significant, safe and viable option for the production of molybdenum‐99 in the future. We believe SHINE will help secure supply for global medical communities and their patients,” said Jan Makela, GM of GE Healthcare Life Sciences Core Imaging. “Because medical isotopes decay so quickly, it’s essential that the United States establish its own domestic production to meet the needs of our 20 million patients each year. In addition, SHINE will contribute to the strength of the global supply chain,” said Greg Piefer, Ph.D., founder and chief executive officer of SHINE. “By entering into this supply agreement with SHINE, GE Healthcare is effectively affirming that SHINE presents the best new option for western production and a strong option for supply around the globe.”
SHINE submitted its Construction Permit application to the Nuclear Regulatory Commission (NRC). This submittal was the first formal step by SHINE in seeking an NRC permit to begin construction of its medical isotope facility in Janesville, Wisconsin. As required by Federal regulations, the Construction Permit application consisted of general information about SHINE, an analysis of environmental impacts from the construction and operation of the facility, if any, and a preliminary safety analysis of the planned facility. SHINE’s filing began the NRC’s 2+ year process of review and approval.
SHINE announced its intention to build its new manufacturing plant in Janesville, Wisconsin. “We are very excited to call Janesville home and to become part of the community as an employer and corporate citizen,” said Greg Piefer, founder and CEO of SHINE. “As a company that grew in partnership with research conducted at the University of Wisconsin-Madison and the Morgridge Institute for Research, one of our primary goals was to stay in-state and take advantage of the dedicated, talented workforce available here. The city leaders of Janesville worked closely with us to ensure that we brought our plant and its potential high-paying jobs into this community.”
The SHINE project was chosen as one of four awardees by the U.S. Department of Energy’s National Nuclear Security Administration to support the development of a new process and manufacturing plant for molybdenum-99 without weapons-usable highly enriched uranium. The $25M award was implemented under a 50%-50% cost-sharing arrangement with DOE/NNSA.
SHINE was founded in 2010 in response to the desperate market need for a domestic supply of medical isotopes, underscored by the failure of the Canadian MAPLE project and the major moly-99 shortage of 2009-2010.