First commercial-sized shipment of medical isotopes to the US
By: Natasha Odendaal
Published: 20 Aug 10
NTP Radioisotopes, a subsidiary of the State-owned Nuclear Energy Corporation of South Africa (Necsa), has successfully delivered the first official commercial-sized shipment of low-enriched-uranium- (LEU-) based Molybdenum-99 (Mo-99) to the US. The shipment arrived in the US on July 21 to under-go a series of quality tests. During the nuclear security summit, held in Washington, in April, Necsa and NTP committed to supply LEU-based medical isotopes to the US. NTP increased the Mo-99 production to deal with the world shortage following the unexpected shutdown, owing to technical problems, of the Atomic Energy of Canada Limited’s National Universal Research medical nuclear reactor, in May last year, reports Necsa.
The US Department of Energy’s National Nuclear Security Administration’s (NNSA’s) global threat reduc-tion initiative provided support for the conversion of NTP’s Mo-99 production process from the use of high-enriched uranium (HEU) to LEU, mak-ing NTP the first large-scale producer of LEU-based Mo-99.The company says that, in the first few months of 2010, NTP performed four consecutive successful commercial-sized LEU-based Mo-99 production runs that allowed the company to evaluate the product quality and performance using its quality and performance systems.
The evaluations demon-strated the satisfactory per-formance of the isotope, allowing NTP to submit a drug master file to the Food and Drug Administration (FDA) in the US for the approval of NTP as a bulk supplier of LEU-based Mo-99, which will serve as an active pharmaceutical ingredient in the US. This submission was made at the end of June. On July 19, NTP completed its first commercial-scale LEU-based Mo-99 production run destined for export and official validation by Technetium-99 (Tc-99M) generator manufacturers, says Necsa.
The production run was successful, with a 90% yield, and was sent to Lantheus Medical Imaging and provider of healthcare products Covidien, in the US, for official evaluations. The data gathered from these productions, as well as the results on the generator performance and Tc-99M quality and efficiency, will be reported to the FDA for final approval and the recom-mendation of the use of NTP’s LEU-based Mo-99 in the US. Further, validation samples have also been sent to Japan, Korea, Israel, China, Poland, and the Netherlands for verification, using processes accepted and approved in these countries.
Meanwhile the technology used to produce Mo-99 was at the core of discussions at the nuclear security summit, in Washington, because weapons-grade uranium is customarily used in this process. With the Obama adminis-tration driving to eliminate the use of weapons-grade uranium around the world, NTP’s LEU route to Mo-99 is receiving a great deal of attention in the US, the company reports. The US Congress has moved to ensure the supply of Mo-99 from LEU in the future. If enacted, the Markey Bill (HR 3276) would authorise the funding and a clear road map to create an indigenous supply of Mo-99 for US patients, while also allowing for adequate time and safeguards for migration to LEU technology.
Further, the global threat reduction initiative has called for proposals for a LEU-based supply of Mo-99 for the US market. The aim of the US call for proposals is for each project to supply 3 000 six-day Curies [unit of radioactivity] a week to the US by the end of 2013, without the use of HEU, says Necsa.
Engineering News
20 August 2010