Contract Manufacturing of IND Radiopharmaceuticals
NCM-USA is equipped with two (2) GE PETtrace cyclotrons and multiple automated synthesis modules used in the GMP production of many F-18 labeled radiopharmaceuticals.
NCM-USA is actively involved as a contract manufacturer of several investigational new drugs (IND) under clinical evaluation as molecular imaging PET probes.
Theranostics is a novel approach rapidly facilitating a paradigm shift from the conventional ‘trial and error’ medicine to ‘personalized medicine’ and holds great promise for improved clinical management and patient outcomes. In nuclear medicine, theranostics is merging radionuclide target specific drug therapy (Rx) and diagnosis (Dx) based on molecular PET and/or SPECT imaging technique (also known as companion diagnostics).
In the last one year, NCM-USA reorganized the manufacturing area and set-up a new GMP (good manufacturing practices) facility for the synthesis of therapeutic radiopharmaceuticals based on alpha (α) emitting nuclide (Ac-225), and beta (β-) emitting radionuclides (Lu-177, Y-90) and target specific biomolecules such as peptides and proteins.
NCM-USA is actively involved as a contract manufacturer for academic medical center and pharmaceutical companies and providing IND therapeutic radiopharmaceuticals for the treatment of treatment of cancer.