a comprehensive kit for preparing the investigational diagnostic imaging agent, 68Ga-PSMA-11

For the Rapidly growing demand for prostate imaging, isoPROtrace kit for labeling with Ga68, is a safe, useful, ready-to-use, PET CT tracer with high detectability for prostate cancer imaging and diagnosis.
Multi-patient dose can be produced and dispensed within 5 Minutes.
The simplicity of the method is highly convenient and easy-to-integrate in any radio-pharmacy or hospital.

isoPROtrace-11 is a one vial ready to use kit for labeling with Ga68 for prostate cancer imaging.
Labeling procedure is similar in principle to cold kits for 99mTc labeling.

Easy to use in routine clinical practice- only one vial.
Short radionuclide preparation time / reaction time.
Less operator-dependent than the synthesizer-based production method.
Minimal risk of operator vs synthesizer-based production method.
Excellent acceptance by technologists and laboratory staff.
Doesn’t have high associated consumables costs.
Doesn’t require a hot cell environment.

isoPROtrace-11 and Eckert & Ziegler
isoPROtrace-11 has been tested by Eckert and Ziegler with their Ga68 generator Galliapharm and KitLab. E&Z are developing an automated procedure for the kit to be used with KitLab.

Paper just released by the Isotopia’s R&D team. entitled “Enhancing Capacity and Synthesis of 68Ga-PSMA with lyophilized ready to use kit for Nuclear Pharmacy Applications”.

The current production is in Scotland in a GMP compliant facility and the peptide is also GMP compliant from ABX (PSMA-11).

3 years unit dose supply using the kit in Isotopia’s radio-pharmacy enhancing production capabilities.

Validated on E&Z Galipharm and tested on leading brands of 68Ga (gallium) generators ITG, IRE.

Currently validated generators reflect >95% of the install base of 68Ga generators in the United States –and globally

E&Z validation to implement labeling on the KitLab-

isoPROtrace-11 is the first cold kit that is automated with KitLab and has successfully been tested with a reaction time of 5 minutes and radiochemical purity of more than 98 %. The required amount of Gallium-68 was eluted from an Eckert & Ziegler
Ge-68/Ga-68 generator. The complete radiollabeling process takes place at room temperature without additional heating. To further facilitate the process, KitLab gives the option to automatically create a quality control sample after the process. It also measures the ambient temperature to avoid errors of result due to wrong temperatures. So far, isoPROtrace-11 has been successfully used in six Israeli PET centers in the past 2.5 years with a typical yield of 99 %. Currently the kit is produced at a GMP manufacturing site in Europe. To extend production capacity and to prepare for clinical trials and registration, Isotopia is aiming to open its own local production facility in the near future.

Since 68Ga can also be produced via cyclotron, we are also validating the kit with 68Ga produced from GE and IBA cyclotrons

We are amending our FDA DMF to include support for cyclotron-produced gallium.

Isotopia’s investment in manufacturing scale-up can support the international market.