Science
GMP Manufacturing
Built for clinical translation
Radiopharmaceutical development requires the targeting molecule, radionuclide, manufacturing process, quality controls and clinical logistics to work as one system.
GMP
Curasight has established GMP experience through the uTRACE® imaging program and the current 64Cu-DOTA-AE105 glioblastoma study within uTREAT®.
Manufacturing activities include peptide-based drug substance and product preparation, radiochemistry, quality control and release procedures appropriate to radiopharmaceutical clinical use. Manufacturing development for subsequent therapeutic product candidates is being advanced in parallel with clinical development.
Platforms
The uTRACE® and uTREAT® platforms use peptide chemistry and radiometal chelation, supporting development of distinct imaging and therapeutic products based on selected ligand and radionuclide combinations.
As individual product candidates advance, manufacturing and radionuclide supply strategies will be scaled and qualified for their specific later-stage clinical requirements.
