Strong clinical potential of radioligand therapy is evident from recently published clinical trial results Global supply shortage of Ac-225 is impacting supply to clinical trials Demand is increasing for high-purity isotopes to conduct and scale up clinical studies and support regulatory approvals in the US and Europe IBC’s state-of-the-art highly selective separation technology, MRT™, for Ra-226 recovery and Ac-225 separation will help to address these issues Ra-226 and Ac-225 are separated at up to 99.99% purity and with 99.9+% recovery yield
AMERICAN FORK, Utah, June 6, 2024 /PRNewswire/ — IBC Advanced Technologies Inc. (IBC) announces commercial availability of specific Molecular Recognition Technology™ (MRT™) flowsheets for highly selective, single-step separation of actinium-225 (Ac-225) and recycling of radium-226 (Ra-226).
Recent critical global shortages of the therapeutic isotope Ac-225 have caused uncertainty around the availability and sustainability of the isotope’s supply chain, and shortages have begun to slow the pace of clinical development, posing an increased risk to continuity of supply in ongoing clinical trials in major cancer indications.
In parallel, increased regulatory scrutiny of the impurity profile of Ac-225, in particular the presence of impurities such as the long-lived radionuclide Ac-227, demands a step-change in the quality, purity and durability of Ac-225 production.
IBC’s innovative flowsheets have been designed specifically to equip producers of Ac-225 to streamline and improve their production processes and enhance the recycling recovery rates of valuable target material, especially Ra-226, thereby alleviating critical shortages for a key therapeutic radionuclide.
Flowsheets for the individual separation of Ac-225 and Ra-226 are based on highly selective MRT™ resins and processes, commercially launched by IBC in 2023.
Manufactured exclusively by IBC in the United States, MRT™ resins consist of predesigned, highly metal-selective ligands covalently attached to solid supports, such as silica gel or polymer substrates. MRT™ resins can be reused repeatedly and individually bind Ac-225 and Ra-226 with exceptionally high selectivity in packed column mode. The bound target Ac-225 or Ra-226 is removed via elution with very high rates of purity and recovery, up to 99.99% pure and 99.9+% yield, using chemically simple solutions. Excellent radiolytic stability and reusability of MRT™ resins ensure a sustainable process with minimal waste generation.
Dr. Robert G. G. Holmes, former Chief Scientist at Canadian Nuclear Labs, commented, "IBC offer proven flowsheets for highly selective separation of Ac-225 and Ra-226. The use of MRT™ resins to obtain exceptionally high yields and purities promise to alleviate the current critical supply shortage by making more Ac-225 available."
Steven R. Izatt, President and CEO of IBC, commented, "IBC’s proprietary MRT™ resins have been shown to achieve exceptionally high recovery yields and purities, as well as radiolytic stability for multiple cycle reusability. MRT™ flow sheets substantially reduce production time, dramatically increase output and generate minimal waste, thereby resulting in a sustainable process for long-term supply of Ac-225. "
Background of IBC
IBC is an award-winning manufacturer and supplier of highly selective separations products, engineered systems and processes using Molecular Recognition Technology™ (MRT™). Based on green chemistry and green engineering principles, IBC’s MRT™ products and associated processes are used worldwide in medical, mining, metals, manufacturing, environmental, analytical and laboratory applications.
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