High-purity terbium-161 produced at scale with two-stage chromatography

Researchers have established a scalable, two-stage chromatographic process for producing no-carrier-added terbium-161, a therapeutic radionuclide viewed as a promising alternative to lutetium-177 for targeted radionuclide therapy, particularly for treating micrometastases. The work, published in EJNMMI Radiopharmacy and Chemistry, addresses one of the main constraints on the clinical development of terbium-161: limited production capacity and the need for efficient separation from irradiated targets.

The team used enriched gadolinium-160 target material, which was irradiated to produce terbium-161. Separation was achieved through sequential chromatography, first with a self-synthesized lanthanide (LN) resin and then with a commercial diglycolamide (DGA) resin. This two-stage process effectively separates terbium-161 from both the target material and its decay daughter, yielding a product with quality attributes the authors describe as suitable for clinical research.

A single production batch yielded 42.38 ± 0.05% GBq of the radionuclide, with a radioactive concentration of 83.7 ± 0.12% GBq/mL. These figures, reported in the study’s abstract, indicate the output levels achieved with the new process, although the published version reviewed here is an early-release, peer-reviewed accepted manuscript that remains subject to further edits before the final version of record.

Quality control results were central to the study. The product met stringent specifications: radionuclidic purity of at least 99.9%, radiochemical purity of at least 99%, and a specific activity of 6.04 × 10¹⁷ ± 0.08% Bq/mol. Concentrations of metallic impurities, including gadolinium, dysprosium, iron, copper, zinc and lead, were all below the required limits, an important consideration for downstream radiopharmaceutical preparation.

The labeled compound maintained a radiochemical purity above 95.8% after 72 hours in saline at ambient temperature, suggesting adequate stability for further development work.

The study’s authors frame the radionuclide as a promising alternative to lutetium-177, which is widely used in clinically applied radiopharmaceutical therapies.

The authors conclude that a reliable and efficient method for the large-scale production of high-purity no-carrier-added terbium-161 has been established. They describe the work as providing a crucial and accessible nuclide source to advance the development of terbium-161-based radiopharmaceuticals, positioning the two-stage LN/DGA resin process as the key technical achievement of the study.

As with any production method described in a research article, the reported yields and quality specifications reflect the conditions of this study, and the authors note that the product’s quality attributes are intended to support clinical research rather than to constitute an approved clinical product. The article is published open access, with the full production and quality control details available in the journal.

Subject of Research: Scalable production and quality control of no-carrier-added terbium-161 from enriched gadolinium-160 targets

Article Title: Production and quality control of no-carrier-added 161Tb from enriched 160Gd target material

Article References: Wang, J., Xiao, C., Wu, M., Wang, J., Yue, H., Zhuo, L., Guo, X., Yang, N., Dang, Y., Yang, X., Liao, W., Li, J., Li, H., Xiong, X., Lin, Q., Wang, D., Tu, J., Huang, Z., Yang, Y., & Zhao, P. (2026). Production and quality control of no-carrier-added 161Tb from enriched 160Gd target material. EJNMMI Radiopharmacy and Chemistry. https://doi.org/10.1186/s41181-026-00495-3

Image Credits: AI Generated

DOI: 10.1186/s41181-026-00495-3

Keywords: terbium-161, lutetium-177, radionuclide therapy, gadolinium-160, chromatography, radiopharmaceuticals, radionuclidic purity, DOTATATE, micrometastases, targeted radionuclide therapy, Production, quality