Galli Eo 68Ge/68Ga Generators

Today many tracers for diagnostic imaging PET (positron emission tomography) use the fluor-18, a radioisotope with short half-life, produced in a cyclotron near the medical examinations, which requires a long and heavy material and financial investment.

Gallium-68 is another radioisotope equally favorable for PET imaging with physical characteristics similar to fluor-18, its half-life is also very short but it has the advantage of being obtained more easily and at lower cost through a generator germanium-68 / gallium-68 used directly in the radiopharmacy.

To facilitate the preparation of radiopharmaceuticals using gallium-68 without compromising the safety of operators and patients, the Galli Eo™ generator produced by IRE ELiT is a fully integrated, closed system to get rapidly highly concentrated and very pure preparations minimizing loss of activity. The design quite innovative limits the risk of error and contamination. Finally, this generator can be used manually or connected to a synthesis module. This optimal system for using labeling kit with gallium-68 will probably enable, thanks to  imaging, a better management of cancer (neuroendocrine cancers, prostate cancer...) and other infectious diseases.

IRE EliT has filed for Marketing Authorization in Europe for its Ge-68/Ga-68 generator, brand name Galli Ad®.

IRE ELiT has also filed in the US a type II Drug Master File (DMF) application with the Food and Drug Administration (FDA) for Galli Eo®, identified by the number #03171. DMF has also been filed with Health Canada for the Canadian market.

Actually we are also producing Ge-68/Ga-68 generators (Galli Eo®) with different status according to the regulations in the recipient countries: IMP (Investigational Medicine Product) or Chemical grade (not for human use) or API (Active Pharmaceutical Ingredient).

• HIGH RADIOACTIVE CONCENTRATION OF THE ELUATE
• NO PRE-PURIFICATION/FRACTIONATION METHOD NEEDED
• EASY TO BUFFER
• NO NEED FOR CLEANING ELUTION AFTER WEEK-END
• STERILITY GUARANTEED
• EXTENDED NUMBER OF ELUTIONS WITH LONG SHELF LIFE: 450 ELUTIONS/ 1 YEAR
• ELUTABLE WITH AN EVACUATED VIAL OR CONNECTED TO AN AUTOMATIC MODULE
• ELUTION IN LESS THAN 3 MINUTES
• “TABLE TOP” USE: REQUIRES MINIMAL INFRASTRUCTURE

• Chemical Form: 68GaCl3
• Activity: 20-50 mCi
• Eluent: Sterile 0.1 M HCl
• Yield: > 67% at release
• Breakthrough: < 0.001%
• Elution time (with vacuum vial): 3 min
• Shielding: Equivalent to 50 mm lead thickness
• Shelf life: 450 elutions /1 year

Please contact us for more details.