TerThera reached GMP status for their Terbium-161 product, improving clinical access by meeting the highest quality standards.
GMP TERBIUM-161 PRODUCT LAUNCHED BY TERTHERA
BREDA, Netherlands, June 5, 2025 /PRNewswire/ -- TerThera B.V. has officially launched the world's first GMP-compliant Terbium-161 NCA, setting a new benchmark in the commercial scale production of this promising radionuclide. Now, with the successful implementation of European Good Manufacturing Practices (GMP), TerThera's Terbium-161 meets the highest quality and safety standards required for clinical trials and patient care across Europe and beyond. This lowers regulatory barriers and accelerates the path to new therapies providing hospitals, clinicians, and researchers immediate access to this next-generation therapeutic radionuclide Terbium-161.
A New Era in Cancer Treatment
Terbium-161 NCA is a no-carrier-added, neutron-activated radionuclide uniquely suited for Radio Ligand Therapy (RLT). With an abundant emission of Auger electrons and high Linear Energy Transfer (LET), combined with similar chemical characteristics to well-known radiolanthanides, Tb-161 brings a high potential to decimate both primary tumors and (micro) metastases. When paired with proven targeting vectors like PSMA, SST, and FAPI analogues, Tb-161 demonstrates a bioequivalence while significantly increasing absorbed doses in all lesions, offering novel treatment options and strategies in cancer healthcare, improving the overall disease control and may even overcome radio-resistant disease.
Global Vision, Local Innovation
"This milestone is more than a regulatory achievement—it's a leap forward in our mission to bring Terbium-161 to patients worldwide," said Philippe van Overeem, CEO of TerThera. "GMP Terbium-161 is now a clinical reality, and this is just the beginning. We are actively constructing a large-scale production facility to meet the growing global demand and expand access to this promising radionuclide for optimized cancer treatments." With this launch, TerThera reaffirms its commitment to transforming the landscape of radiopharmaceuticals and leading the charge in precision oncology.
About TerThera BV
TerThera is a radionuclide production-focused company based in The Netherlands. The founders and staff of TerThera have decades of experience in the nuclear medicine industry and are highly dedicated to bringing the innovative radionuclide Terbium-161 (Tb-161) to the clinic. TerThera is building a global platform including GMP production facilities in Europe, USA and Asia to meet the growing demand for radionuclides in RLT.
Share this article