Supply Innovation

Along with the large demand for Tc-99m, there are significant supply side issues that jeopardize the reliable supply of Tc-99m. Supply disruptions and constraints are the key concern of radioisotope buyers and over 90% of professionals said they have suffered from recent Tc-99m shortages. Current supply constraints and disruptions are caused by the unreliability of the aging nuclear reactors that currently produce the source material of Tc-99m.

Mo-99 made in nuclear reactors is sourced from relatively few research reactors. Over 90% of Mo-99 is made in five reactors. These facilities have experienced several shutdowns over the past decade. In fact, all of the facilities are around 50 to 60 years old and experience continual unanticipated shut downs. Even worse, several of these reactors are set to be retired in the near future.

Medical isotopes come with the unique challenge of decay – the Mo-99 isotope takes 66 hours to decay into the medical isotope Tc-99m. The new isotope has a half-life of only six hours, which means much of the Tc-99m is wasted in shipment from the nuclear reactors where they are produced.

Given the short half-lives of the isotopes and resulting decay of the key ingredient, the supply chain is incredibly time critical. It is not possible to stock-pile inventory of the isotope in the event of shortages. When the National Research Universal Reactor shut down in 2009, it removed 40% of the world supply of Tc-99m. Health officials in Canada and the United States scrambled to find alternative sources, and thousands of tests and treatments were rescheduled. Given the lack of diversity in supply sources and the linear nature of the supply chain, an issue with one source or at one link in the supply chain can immediately affect medical facilities’ ability to adequately care for patients.

At CII, we use linear accelerators to produce pure Mo-99, process it and then ship it directly to radio-pharmacies and hospitals, which halves the conventional reactor supply chain distribution time and greatly reduces the distribution costs.

Current Reactor Isotope Supply Chain

Current reactor supply chain

Currently, the Mo-99 supply chain is quite complicated, requiring several points of processing. The first step involves the irradiation of Highly/Low Enriched Uranium targets in a nuclear reactor to produce Mo-99 along with various other isotopes. This process takes approximately six days. The product is then sent to Mo-99 processing facilities where the Mo-99 is chemically separated. The raw Mo-99 once isolated is then shipped to a generator facility as a bulk liquid so it can be used to make Mo-99 generators. The generators that meet quality criteria are then sent through the distribution channel, during which it decays into Tc-99m.  Hospitals and radio-pharmacies receive the generators and extract the Tc-99m to make diagnostic radio-pharmaceuticals.

CII’s Isotope Supply Chain

New linear accelerator supply chain

CII’s supply chain is greatly simplified. The LINAC produces a mix of Mo-100 and Mo-99 in solution from the Mo-100 target. The Mo-100/Mo-99 is shipped to radio-pharmacies and hospitals, where, once extracted, the resulting Tc-99m can be used to create diagnostic injections.

Another benefit of CII’s process is that the Mo-100 can be recycled and reused as a target to make more Tc-99m. Our shipments are made in returnable containers that we retrieve and reuse with no loss of quality. The Tc-99m is as pure as the first.