Centralised manufacture of Molecularly Targeted Radiation (MTR) drugs for cancer treatment

Providing better access to life-changing treatments for cancer patients

Challenge

Molecularly Targeted Radiation (MTR) is a direct and effective way to diagnose and treat cancer. Traditional MTR drugs use short-lived radioisotopes to either release a diagnostic ‘signal’ for imaging with a PET-scan or deliver tumour-killing radiation to the cancer cells as a targeted therapy. Unfortunately, short-lived radioisotopes can only be prepared locally at hospitals and must be injected immediately, resulting in a dispersed manufacturing capability and with no or little opportunity to distribute these life-changing MTR drugs across Australia, and beyond.

Proposed Solution

In this two-year manufacturing research project, Telix Pharmaceuticals brings together Cyclotek, iPhase Technologies, GenesisCare and the School of Chemistry, Bio21 Institute, University of Melbourne to advance Australian manufacturing capabilities for MTR drugs for prostate, kidney and neuroendocrine cancers.

The project aims to develop a more efficient, centralised manufacturing process for MTR drugs using long-lived radioisotopes zirconium-89 (89Zr) and lutetium-177 (177Lu) to support early-phase clinical evaluation and then the transfer to a current Good Manufacturing Practice (cGMP) production environment.

Success of this project will enable for the first time a consolidation of the manufacturing of these potentially life-saving drug types to an internationally-recognised ‘cGMP’ standard within a single site which will allow distribution to patients across the whole of Australia and for export to countries serviced by major airline routes from Australia.