Bulk Scale Formulation of Therapeutic Doses of Clinical Grade Ready-to-Use Lu-DOTA-TATE: The Intricate Radiochemistry Aspects.

Introduction: Lu-DOTA-TATE is a clinically useful and promising therapeutic radiopharmaceutical for peptide receptor radionuclide therapy of neuroendocrine tumors (NETs) overexpressing somatostatin receptors. Currently, the radiopharmaceutical is prepared in-house at nuclear medicine centers, thereby restricting its use to limited centers only. In this article, the authors describe systematic studies toward bulk scale formulation of "ready-to-use" Lu-DOTA-TATE using medium specific activity Lu (740-1110 GBq/mg) at a centralized radiopharmacy facility.