Orano Med, a biotechnology company based in the US, will build a new Alpha Therapy Laboratory (ATLab) in Onnaing, France. It will be the first industrial-scale pharmaceutical manufacturing facility in Europe dedicated to producing the lead-212 radioligand therapies known as targeted alpha therapies (TAT).
The facility will focus on manufacturing lead-212 therapies developed by Orano Med and distributing them across Europe. The project is aligned with France’s biotherapy-bioproduction acceleration strategy, focusing on the development and production of new biotherapies, especially in the field of oncology.
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Orano Med’s combined production capabilities, including the ATLab Laboratory in Onnaing and another similar upcoming facility in Indianapolis, US, are projected to yield 10,000 doses per year by 2025.
Construction of the ATLab commenced with a ground-breaking ceremony in February 2024. The facility is expected to create 25 direct jobs with the production phase to begin in 2025.
Location
The new ATLab will be situated in Valenciennes, Onnaing, France. The ATLab Valenciennes will benefit from the industrial network of the Valenciennes metropolitan area and the Hauts-de-France region. Its proximity to Brussels and Roissy-Charles De Gaulle (Paris) international airports is one of the key factors in the selection of the location.
Orano Med’s ATLab Valenciennes details
The ATLab Valenciennes will cover a total area of more than 3,000m² (32,292ft²) and produce new targeted lead-212 alpha therapies for cancer patients on a large scale.
A modular design will be used for production lines, enabling the addition of more lines in the future. The flexibility will allow for the manufacture and distribution of multiple drugs simultaneously, potentially increasing efficiency and scalability in pharmaceutical production.
The facility will initially produce 5,000 patient doses a year, with plans to expand the output tenfold by the end of the decade. The initial dose is planned for release in mid-2025.
Funding
The ATLab Valenciennes is being developed with a €29m ($31m) investment. The project is supported by the Hauts de France region and the Valenciennes metropolitan area. It is also a recipient of the Industrialisation and Health Capacities 2030 call for projects, within the France 2030 plan, making it eligible for public aid of €3.8m ($4.1m) from a total investment of €29m.
Details on lead 212-based radioligand therapies
Lead-212, an alpha-emitting radioisotope from the thorium-232 decay chain, is exceptionally rare and potent as a therapeutic payload against cancer cells. Orano Med leverages its expertise in advanced nuclear technologies to extract and purify lead-212, using it in several promising targeted cancer treatments known as TAT.
TAT utilises lead-212 in conjugation with diverse biological molecules, such as peptides and antibodies, to effectively target and destroy cancer cells. The approach allows TAT to selectively identify and eliminate cancer cells, minimising harm to adjacent healthy cells.
Orano Med’s lead-212 manufacturing process
Orano Med has pioneered a process for large-scale, cost-effective production of high-purity 212Pb (lead-212) using thorium-232. With 22,000 drums of purified thorium-232, the company is well-equipped to meet the global demand for TAT.
The patented chemical process involves multiple extraction and purification stages to isolate lead-212 from thorium-232 descendants, including radium-228, thorium-228 and radium-224. Orano Med’s production and drug chain is fully integrated and independent of external radionuclide suppliers.
Contractors involved
Bouygues Energies & Services, an engineering, installation and maintenance services provider based in France, is associated with the construction works of the project and is responsible for all the technical operations, including heating, ventilation and air conditioning, electricity, special fluids, cleanroom partitions, laboratory equipment and pneumatic transport.
Marketing commentary on Orano Med
Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company specialising in developing targeted cancer therapies using lead-212. The company employs 110 people across France and the US and has 12 patented innovations. It has two current ongoing clinical trials, two preclinical laboratories for alpha treatment development and one global industrial platform for lead-212 manufacturing.
Orano Med’s global industrial platform ensures the production and distribution of 212Pb-conjugated drugs. In France, the Laboratoire Maurice Tubiana (LMT) manages the process’ upstream phase and produces the precursors of lead-212 from which the lead-212 doses are extracted, while the Domestic Distribution & Purification Unit (DDPU) at Plano in Texas, US, produces 212Pb for North America from precursors supplied by LMT. They also supply for clinical trials as per GMP standards.
Given lead-212’s short half-life of 10.6 hours, the therapies require production close to hospitals, necessitating the construction of additional ATLabs to meet global patient needs.
The first ATLab, being built in Brownsburg, Indiana, US, will commence production in 2024. Additional ATLabs are also planned to meet global demands.
