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Industrial platform
Orano Med has developed a patented chemical process allowing production of 212Pb on a large scale and at a reasonable cost
Development of targeted alpha therapy has long been hindered by a lack of supply of alpha emitting radioisotopes meeting three important criteria: purity meeting radiopharmaceutical standards, reliable production capacity sufficient to meet global needs, and economic competitiveness.
With a unique and proprietary source of raw material (thorium-232), Orano Med has developed a process allowing production of very high-purity 212Pb on a large scale and at a reasonable cost.
Large-scale, reliable and independent 212Pb production capacity
212Pb is a radioactive element from the decay chain of thorium-232, a radioisotope that occurs naturally on Earth. From the Orano group's former activities, Orano Med has 22,000 drums of purified thorium-232 at its disposal, a sufficiently plentiful stock of raw materials to cover global needs for Targeted Alpha Therapy.
Moreover, after initial extraction of the daughter elements it contains, the thorium-232 is retained. Given this radioisotope's extremely long half-life (14 billion years), it will produce descendants again, allowing 212Pb to be extracted again a few years later. Every drum can thus be re-used indefinitely to produce 212Pb.
The patented, entirely chemical process, developed by Orano Med consists of several successive steps of extraction and purification of descendants of thorium-232: radium-228, thorium-228, radium-224 and finally lead-212. Not having recourse to either nuclear reactors or particle accelerators, the chain for the production of 212Pb and the drugs is fully integrated within Orano Med and is independent of external radionuclide suppliers.
Facilities that are unique in the world
In order to produce 212Pb-conjugated drugs and distribute them, Orano Med has developed a global industrial platform.
In France at Bessines-sur-Gartempe in the Haute-Vienne, the Laboratoire Maurice Tubiana (LMT) is implementing the upstream phase of the process: the production of radium-228 and thorium-228 from which the doses of 212Pb will be extracted. It can also call upon the support of its associated research and development center (Centre de Recherche et Développement – CRD). Orano Med is thus continuously optimizing its processes to be better and better at meeting the challenges of industrialization, quality, and protection of the environment, as well as the specific demands of its partners. A larger facility is being planned for the future to industrialize this process and cover global needs in the drug commercialization phase.
The Laboratoire Maurice Tubiana can also produce 212Pb for clinical trials in Europe.
The Laboratoire Maurice Tubiana can also produce 212Pb for clinical trials in Europe.
In the USA at Plano in Texas, the Domestic Distribution & Purification Unit (DDPU) produces 212Pb for North America from precursors supplied by the LMT. It also manufactures drugs for clinical trials in accordance with GMP standards assembling the 212Pb with the chelating agent and the targeting molecule.
In the USA at Brownsburg in Indiana, the first Alpha Therapy Laboratory (ATLab) is responsible for the large-scale production of 212Pb radioligand therapies and their distribution in North America, from thorium-228 supplied by the LMT.
In France, an ATLab is also under construction in Onnaing, near Valenciennes. Likewise, it will commence the large-scale production of 212Pb radioligand therapies and their distribution in Europe as of 2025. Based on a modular design, further production lines may be added in the future to allow for the manufacturing and distribution of several drugs simultaneously.
Given the half-life of 212Pb (10.6 hours), the drugs must be produced close to hospitals. The construction of other ATLabs are planned to cover global needs.
In 2011, Orano Med also acquired Macrocyclics which has globally-recognized expertise in the production and development of chelating agents for nuclear medicine. It is also located in Plano, Texas.