Standardisation of the procedure for the preparation and quality control of [177Lu]Lu-PSMA-D4, a radioligand for the treatment of metastatic prostate cancer
(IAEA Research Contract No. 28149)
The aim of the project is to develop cGMP-compliant technology for the manufacture of PSMA-D4 active substance (API) and radiopharmaceutical kits for labelling with various medical radionuclides, including 177Lu, to prepare radiopharmaceuticals for the treatment of castration-resistant metastatic prostate cancer (mCRPCa).
The composition of the kits will be optimised to provide one-step preparation of radiolabelled PSMA-D4 ready for patient administration, without the need for post-labelling purification. The kits will be manufactured under GMP conditions. Quality control methods will be developed and validated for both the API and kits, as well as the radiolabelled preparation. Standardisation will ensure reproducible production of radiopharmaceutical kits meeting all quality parameters and, in addition, will enable replication of such a manufacturing pathway for a modified active substance with better radionuclide binding parameters than substances based on the bifunctional chelator DOTA.
Duration of the project:
2023.10.09 – 2028.11.01
19%
Source of financing:
The project is co-financed by the International Atomic Energy
Grant amount:
256 000.00 EUR
Grant amount for OR POLATOM (NCBJ):
15 000 EUR
OR POLATOM Project Manager:
dr hab. Piotr Garnuszek
