
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.
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.
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. The Laboratoire Maurice Tubiana can also produce 212Pb for clinical trials in Europe.
Still in Bessines-sur-Gartempe, a larger facility called Advanced Thorium Extraction Facility (ATEF) is under construction to industrialize the upstream phase of the process and meet global demand. It will be the world's first industrial facility dedicated to the production of thorium-228, the precursor to lead-212, for radioligand therapy applications. This project marks a major milestone in the availability of innovative cancer treatments. Covering an area of 7,000 m², ATEF is set to be operational in 2027 and will increase the current production capacity of the Maurice Tubiana laboratory by ten times.
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.