AdvanCell
²¹²Pb Generator
2022
Research, Concept, Development, Electronics + Production
AdvanCell Isotopes ²¹²Pb Generator
A world-first alpha isotope generator which addresses the greatest unmet need in targeted alpha therapy: the reliable + scalable supply of isotope.
AdvanCell is an Australian clinical stage radiopharmaceutical company with a platform technology for a revolutionary cancer treatment called Targeted Alpha Therapy. AdvanCell's Generator is a world-first alpha isotope generator which addresses the greatest unmet need in targeted alpha therapy – the reliable and scalable supply of isotope. The manufacture of clinical doses of a high-value isotope Alpha 212® (Lead-212) for use in targeted radionuclides therapy is a game-changer for prostate and several other cancer treatments.
Enabling scalable local isotope production capability, the Generator will fast track the delivery of cutting-edge cancer treatments to patients. A focus on quality, reliability and traceability and a goal of a GMP product will provide clinicians with access to mission critical medicines when needed, and not only when and if available. The Generator is currently producing clinically useful amounts of Lead-212 daily and is being used by researchers in Australia.
Scalable Production.
Current production methodologies severely impact the availability of radionuclide therapy and limits access for patients in need.
The challenge was to design + engineer a small footprint generator that could be produced and operated at scale around the state, country + world to serve large patient populations. The generator needed to shield operators from radiation, be intuitive to use and enable reliable production of radio isotopically pure product for an extended period. The goal was to cultivate a design that would encompass all aspects of the electronics + mechanical apparatus that are used to automate the novel production of the high-value isotope (Lead-212). The generator would be required to run continuously for 24-hours to produce clinical doses. Lead-212 possesses a half-life of 10.6 hours. By making the Lead-212 isotope available for treatment at hospitals around the world, AdvanCell's Isotope Generator has the ability to be the integral platform for the development and delivery of novel cancer treatments.
ERGONOMIC + SAFE
Optimised for the safe use of operators within space and time constrained conditions behind protective lead shielding.
Completely automated process reducing the risk of radiation exposure to operators.
COMPACT + PORTABLE
Bench-sized mechanically compact + portable isotop generation device.
Several complex sub-assemblies into a volume production solution (DFM).
HIGH-QUALITY
High-quality materials to ensure long operational life, superior structural integrity + operator safety.
Tungsten shielding + 316 stainless steel construction to shield radiation / protect sensitive electronic control systems.
Accelerating alpha radioligand therapies.
Enabling scalable production at the clinic provides greater opportunity for the development of new forms of alpha radioligand therapies, and increases access to this rare high-value isotope to care providers to deliver life-saving treatments to patients.
The Isotope Generator is a powerful complex system presented in an intuitive and minimal form. The generator balances restrained dimensions and pinpoint positioning of critical elements that flow neatly into a compact device. Using soft whites and stainless steel, the generator fits perfectly in a hospital or clinical environment. The Generator is an innovative combination of argon gas supply, high-temp steam delivery and vacuum capability within a compact system that replaces the typically half of a room of equipment used in current production methods. The generator is long lived, unlike existing designs which cannot scale, and must be replaced weekly. The generator was designed to run daily for a period of up to 18 months before requiring service. The total life span of the device is estimated at 10-years.
The parent isotope is loaded in the top and secured by a removable disc of milled tungsten and screwed shut by the operator (behind shield). The device is centred around a circular LED that indicates the operating status of the generator. Once operation begins, the user can leave the generator unaccompanied for 24-hours while the parent isotope decays. Throughout the production period the device uses a combination of pressurised argon gas delivery, and high-temperature steam cleaning under vacuum, to harvest the Lead-212. All elements of the system and device have been developed to comply with applicable research device standards and regulations.
