Isotopia is happy to announce that the Tech- Transfer of isoPROtrace-11 production to our newly acquired sterile plant has come to a successful end.
isoPROtrace-11 is a PSMA-11 kit for labeling with Ga68 a proven technology used to accurately image and stage metastatic prostate cancer, a 1 vial 1 step preparation kit.
“We are exited to be able to manage the production under our own umbrella and to establish the sterile plant for innovative Theragnostic products” says Tzahi Levy, general manager of the plant.
Isotopia will soon move to produce 3 registration batches for the DMF.
The first GMP batch from this site is now available.
Thank you to our development team and sterile plant team for making this happen.