IBC launches RadSep, Inc.: Best-in-class, highly selective separations using Molecular Recognition Technology™ (MRT™) for production of critical radioisotopes essential to cancer therapies

• Best-in-class, highly selective separations technology for the radiopharmaceuticals industry
• Exhibitor at the European Association of Nuclear Medicine (EANM) Congress in Hamburg, Germany 20-23 October 2024 at Booth S14 (Exhibition Hall 3)
• Over 36 years of experience with first generation flowsheets for highly selective separation of radium (Ra), lead (Pb), thorium (Th), actinium (Ac), bismuth (Bi), copper (Cu) and others
• Highly selective purification of Ra-228 incorporated in Pb-212 flowsheet used by OranoMed to produce AlphaMedix for treatment of neuroendocrine tumors (NETs)
• Second generation flowsheets to drive increased availability and scaleability of critical radioisotope supply, including Pb-212, Ac-225, Ra-226, Th-227, Bi-213 and others
• Highly selective recovery of radium to nanogram per liter concentrations from brines, mining streams and nuclear wastes
• Waste minimization
• Industrial manufacturing capability

AMERICAN FORK, Utah, Oct. 3, 2024 /PRNewswire/ -- IBC Advanced Technologies Inc. (IBC) announces the launch of its subsidiary, RadSep Inc. (RadSep), dedicated to best-in-class, highly selective separations technology for the radiopharmaceuticals industry.

RadSep's proprietary Molecular Recognition Technology™ (MRT™) introduces a comprehensive approach to separating upstream radioisotopes used in the production of feedstocks, as well as downstream radioisotopes used directly in the manufacture of drug products for radioligand therapies (RLTs). When embedded in a production process, including in a Current Good Manufacturing Practice (cGMP) environment, MRT™ enables highly selective, single-step separation of critical radioisotopes, benefiting the supply chain and alleviating shortages caused by sub-optimal separation processes, such as ion exchange resins. MRT™ can thus be used in the industrial setting in order to conserve and recycle critical radioisotopes such as Ra-226.

MRT™ ligands are tailored to target specific ions in terms of matching their shapes and co-ordination chemistry. These molecules are covalently attached to support materials such as organic polymers or silicates to create reusable MRT™ resins that bind metals with exceptional selectivity in packed column mode, including radioisotopes of radium, lead, thorium, actinium, bismuth, copper and others. The bound target radioisotope 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. Independent expert studies have shown MRT™ resins to have:

• Lowest cost of use and least waste generation (compared against four other resin-based protocols for Ra-226 separation) ¹
• High selectivity, more rapid procedures, decreased costs and reduced waste ²
• Strong retention of radium over the entire acid range of 0.01–10 M HCl and HNO₃, with distribution coefficients (K_d) of >250 L/kg ³
• Radium recovery approaching 100% ⁴

Recent global shortages of the therapeutic radioisotope Ac-225, as well as difficulties with upscaling supply of other alpha emitters such as Pb-212, have caused uncertainty around the availability and sustainability of numerous radioisotopes. Supply outages and increasingly critical shortages have begun to impact the pace of clinical development, posing an increased risk to continuity of supply for dozens of ongoing and planned oncology clinical trials. 

In parallel, increased regulatory scrutiny of the impurity profile of starting materials and radioisotopes used in therapeutic drug products (Ac-225 and Pb-212) demands new technology be made available to manufacturers, delivering a step-change in the quality, purity and durability of radioisotope production. 

IBC's innovative MRT™ flowsheets, launched in 2023, have been designed specifically to equip producers of Ac-225 and Pb-212 to streamline and improve their production processes and enhance the recycling recovery rates of valuable target radioisotopes, especially Ra-226 and Th-228.

Dr. Robert G. G. Holmes, former Chief Scientist at Canadian Nuclear Labs and RadSep Advisory Board member, commented, "Molecular Recognition Technology™ is ideally suited to separation of high value medical radioisotopes and their precursors using high selectivity and recovery, pure recovered radioisotopes, reusability and high radiation resistance. These factors play into simple, one-step separative processes with low waste generation and maximum return of the high value products. These features present an economic application. MRT™ is a natural choice for medical radioisotope generation."

John Carney, RadSep Advisory Board member, commented, "High quality materials such as RadSep's best-in-class MRT™ resins and chelators for radiopharmaceuticals, which do not impact the purity of downstream cGMP drug product manufacturing, are essential in order to quicken the pace of innovations and regulatory approvals of novel radiopharmaceuticals. Moreover, RadSep's green chemistry will reduce the environmental impact of radioisotope manufacturing, as the industry scales up in the next decade, to become a major modality for continuous treatment of cancer patients around the world."  

Steven R. Izatt, President and CEO of IBC, commented, "RadSep builds on IBC's foundation of over three decades of highly selective separations expertise. With the capability to produce MRT™ resins at industrial scale, RadSep is uniquely positioned to supply the growing radiopharmaceutical industry with highly efficient separation flowsheets needed for commercial radioisotope production." 

Background of IBC and RadSep

RadSep, Inc. is a subsidiary of IBC Advanced Technologies, Inc., an award-winning manufacturer and supplier of highly selective separations products, engineered systems and processes based on MRT™.
https://radsep.com/
https://ibcmrt.com/

References

1. Roulier M. et al. Comparison of radium-226 separation methods based on chromatographic and extraction resins for its determination by ICP-MS in drinking waters. J Mass Spectrom. 2024; 59(2): e5005.
2. Coha, I. et al. Synergy of flow injection system and molecular recognition technology products for rapid determination of Sr-89, 90, and Pb-210. Talanta 2021; 225: 121959.
3. Thakur P. et al. Optimal methods for preparation, separation, and determination of radium isotopes in environmental and biological samples. Journal of Environmental Radioactivity 2021; 228: 106522.
4. Verlinde M. et al. A new rapid protocol for Ra-226 separation and preconcentration in natural water samples using molecular recognition technology for ICP-MS analysis. Journal of Environmental Radioactivity 2019; 202: 1-7.