TerThera B.V. has officially launched the world's first GMP-compliant Terbium-161 NCA, marking a significant milestone in the commercial scale production of this promising radionuclide for cancer treatment. The successful implementation of European Good Manufacturing Practices (GMP) ensures that TerThera's Terbium-161 meets the highest quality and safety standards required for clinical trials and patient care across Europe and beyond.
This achievement lowers regulatory barriers and accelerates the path to new therapies, providing hospitals, clinicians, and researchers immediate access to this next-generation therapeutic radionuclide. The GMP compliance represents a crucial step in making Terbium-161 a clinical reality for cancer patients worldwide.
Unique Therapeutic Properties
Terbium-161 NCA is a no-carrier-added, neutron-activated radionuclide uniquely suited for Radio Ligand Therapy (RLT). The radionuclide demonstrates exceptional therapeutic potential through its abundant emission of Auger electrons and high Linear Energy Transfer (LET), combined with similar chemical characteristics to well-known radiolanthanides.
These properties enable Tb-161 to bring high potential to decimate both primary tumors and micrometastases. When paired with proven targeting vectors like PSMA, SST, and FAPI analogues, Tb-161 demonstrates bioequivalence while significantly increasing absorbed doses in all lesions, offering novel treatment options and strategies in cancer healthcare.
The enhanced dosing capability may improve overall disease control and potentially overcome radio-resistant disease, addressing a significant unmet medical need in oncology.
Global Expansion Plans
Philippe van Overeem, CEO of TerThera, emphasized the significance of this milestone: "This milestone is more than a regulatory achievement—it's a leap forward in our mission to bring Terbium-161 to patients worldwide. GMP Terbium-161 is now a clinical reality, and this is just the beginning."
The company is actively constructing a large-scale production facility to meet the growing global demand and expand access to this promising radionuclide for optimized cancer treatments. TerThera is building a global platform including GMP production facilities in Europe, USA and Asia to meet the growing demand for radionuclides in RLT.
Company Background
TerThera is a radionuclide production-focused company based in The Netherlands, with founders and staff possessing decades of experience in the nuclear medicine industry. The company is highly dedicated to bringing the innovative radionuclide Terbium-161 to the clinic and transforming the landscape of radiopharmaceuticals while leading the charge in precision oncology.
With this launch, TerThera reaffirms its commitment to advancing radiopharmaceutical development and establishing new standards in the field of targeted cancer therapy through innovative radionuclide production and distribution.
