• GLOBAL Mo-99 SUPPLY CHAIN

    The world's demand for Mo-99 is met by a highly complex supply chain.  The process, from start to finish, has very tight timelines.  Any manufacturing or transportation delays result in significant product decay. Variables within each part of the process must be addressed in order to achieve success.

    Global Supply Map 700

  • Limited suppliers involved in the global manufacture of Mo-99

    • 8 main reactors producing medical isotopes
    • 5 Mo-99 processing facilities
    • 6 generator manufacturing facilities

    Transportation Challenges

    • Customs, government regulations, limited flight schedules, and unpredictable weather all play a role in potential manufacturing and  delivery delays.

    Age of the infrastructure

    • Average age of the 8 main medical isotope producing reactors is over 40 years old.
    • The industry is encountering an increasing amount of unscheduled maintenance and down time as a result of the aging reactor infrastructure.

    Global Mo-99 supply is a highly complex and fragile system. When the supply chain is operating at optimal levels, below is the standard process for producing Mo-99.

     

    supply chain

     

    1   U 235 Targets
    Molybdenum 99 (Mo-99) is produced in nuclear reactors utilizing either Highly Enriched Uranium 235 (HEU) or Low Enriched Uranium 235 (LEU) targets.  These targets, either tubular or flat and of varying size, are fabricated as small from HEU or LEU and aluminum designed specific for each reactor.
    2   Reactor Facility
    HEU or LEU targets are placed in or near the core of the reactor.  The location within the reactor allows high neutron fluxes to surround the HEU / LEU.  Fission reactions occur resulting in production of Mo-99 and a number of other isotopes.
    3   Mo-99 Facility
    After approximately six days in the reactor, fission produced Mo-99 has reached an optimum level.  The targets are then removed and transferred to a Mo-99 processing facility where the targets are dissolved and chemically separated.  Mo-99 facilities can only accept HEU / LEU targets from specific reactors for various reasons, including geographic location (proximity to the reactor), required technical specifications and regulatory authority approval.   The finished product raw material Mo-99 is then isolated as radiochemical and shipped to the next stage in the process.  
    4   Generator Facility
    The radiochemical Mo-99 is transferred to a manufacturing facility in specialized transport containers via various overnight or same day shipping arrangements so it can be used to make Mo-99/ Tc-99m generators.  Generator manufacturing is a health authority approved complex multistep process.  Finished product generators must meet all approved specifications as spelled out by the manufacturer's registered drug application as filed with the appropriate governing regulatory agency.
    5   Pharmacies /Hospitals
    Generators that meet the specific quality release criteria will move on to the distribution channel.  Any of a variety of transportation methods may be necessary including air, ground, or a combination depending on customer location.   The generators are then shipped for same or next day delivery to hospitals and radiopharmacies for elution and used to make diagnostic radiopharmaceuticals.