Radiopharmaceutical CDMO, SpectronRx, and Belgian Nuclear Research Centre, have announced advanced plans to establish a European radiopharmaceutical CDMO (rCDMO) facility, on the Belgian Nuclear Research Center premises in Mol, Belgium.

The collaboration will see both companies working together to meet the rising demand for radioisotopes, particularly Actinium-225, which plays a crucial role in targeted radiotherapies for cancer treatment. The facility will offer end-to-end solutions, from isotope production to radiopharmaceutical development and manufacturing, and strengthen Europe's position in the radiotherapy market.

The following article originally appeared in BioSpace.

SpectronRx, a leading radiopharmaceutical contract development and manufacturing organization (rCDMO), has taken the next step in establishing its first European radiolabeling facility. Today, the company announced that it has executed a binding agreement for the completion of its new rCDMO facility on the Belgian Nuclear Research Center (SCK CEN) premises in Mol, Belgium. The build-out of the new facility is scheduled to be completed by November 2024, with an expected operational date of Q1 2025, pending GMP certification approval.

“By strengthening our partnership with SCK CEN, we have taken the next big step in our commitment to building a next-generation radiopharmaceutical contract development and manufacturing facility in Belgium,” said John Zehner, CEO of SpectronRx. “The facility will enable us to support our European customers in providing healthcare professionals and patients better access to their life-saving radiopharmaceuticals, including Actinium-225-labeled drug products. We are grateful to our partners at SCK CEN for their support, and we are excited to join the European radiopharmaceutical community and the patients they serve.”

SpectronRx signed a Memorandum of Understanding (MOU) with SCK CEN for the Belgium facility in 2023. This new agreement solidifies the partnership, whereby SpectronRx will be responsible for providing state-of-the-art equipment and GMP-qualified procedures. SCK CEN will supply the necessary resources to support SpectronRx in meeting its development and manufacturing objectives. The brand-new facility will first focus on the labeling of Actinium-225-based (Ac-225) radiopharmaceuticals for therapy.

“Our latest agreement with SpectronRx is a critical next step in our efforts to improve access to life-saving radiopharmaceutical drugs,” said Koen Hasaers, Director of Nuclear Medical Applications at SCK CEN. “With the ever-expanding pipeline of Ac-225-based radiopharmaceuticals making progress toward EMA approval, there are promising perspectives that the prognosis and quality of life for cancer patients and those with other diseases could substantially improve. However, the excitement around these therapies has consequently increased demand for Ac-225-labeled drugs, leading to notable shortages. But soon, we will be able to strongly contribute to meeting that demand, which is what makes this project so worthwhile.”

Exceptional cancer fighter

What makes Ac-225 so sought-after is that amid numerous clinical trials, research shows that it can be an exceptional cancer fighter. Actinium-225 is intended to treat prostate, lung, colon, breast, pancreas, blood, and kidney cancers, as well as glioblastoma, a very invasive brain cancer. When attached to a molecule, Ac-225-powered radiopharmaceuticals can selectively target cancer sites and destroy cancerous tissue with minimum damage to healthy cells. Unfortunately, until recently, only small amounts of Ac-225 were available.

Strengthening cancer research globally

“The Belgian Nuclear Research Center is globally known as one of the leading producers of medical radioisotopes and is committed to strengthening radiopharmaceutical research and development,” said Anwer Rizvi, President of SpectronRx. “We have also developed an innovative way to produce Ac-225 from multiple source elements. As such, we are confident in our ability to manufacture Ac-225-labeled drugs at scale, furthering our common mission of accelerating the fight against cancer.”

SpectronRx currently has over 170,000 sq ft of rCDMO space and 150 employees across five locations, serving 29 countries. The company’s highly trained radiopharmaceutical professionals work hand-in-hand with more than 31 pharmaceutical companies to develop and produce life-saving nuclear medicines, including those radiolabeled with Ac-225.

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