ICNAS/University of Coimbra granted with first EU marketing authorization for the distribution of cyclotron produced Gallium-68

ICNAS/University of Coimbra granted with first EU marketing authorization for the distribution of cyclotron produced Gallium-68

The Institute of Nuclear Sciences Applied to Health (ICNAS) from the University of Coimbra (UC) and IBA announce the granting of the first EU marketing authorization for the distribution of cyclotron-produced Gallium-68 using a liquid target for human use

Coimbra, Portugal, 28 September 2021 – ICNAS/UC, leading institution in molecular probe development and molecular imaging and IBA (Ion Beam Applications S.A., EURONEXT), the world's leading provider of solutions for the diagnosis and treatment of cancer, today announce that the Portuguese regulatory agency (INFARMED), has granted the first EU marketing authorization to distribute [68Ga]GaCl3 with a new process for producing gallium-68 with an IBA cyclotron using a liquid target.

68Ga has played an outstanding role in clinical research worldwide, particularly in routine clinical studies for oncological applications with Positron Emission Tomography (PET), during the last 10 years. In particular, 68Ga is very well suited as a diagnostic isotope for pairing with therapeutic radiometal isotopes (ex: 177Lu and 225Ac). The growth of 68Ga in routine clinical applications is mainly due to the [68Ga]Ga-PSMA-11 for PET imaging of the prostate specific membrane antigen (PSMA). The imaging of PSMA expression with [68Ga]Ga-PSMA-11 and PET/CT has proven to be a highly  specific and sensitive tool for patient management.

“This optimized new production process is the result of the strong collaboration between IBA and ICNAS” said Bruno Scutnaire, Vice-President of IBA's RadioPharma Solutions Division.

This FGD-like production process is easy to implement and allows cyclotron production centers to maximize the use of their equipment. The process consists of the irradiation of an enriched 68Zn solution in a 68Ga liquid target installed on a Cyclone® KIUBE. The target solution is then transferred to a Synthera® extension module which purifies the irradiated solution to obtain [68Ga]GaCl3, which is equivalent to [68Ga]GaCl3 from the commercial 68Ge/68Ga generators.

“Currently, the availability and efficiency of 68Ge/68Ga generators is not enough to meet global demand and they have limited elution capacity per day and decay over time, while the 68Ga-cyclotron process allows stable, on-demand production throughout the whole year” commented Antero Abrunhosa, Director at ICNAS.We can see a clear benefit to producing 68Ga with a cyclotron using a liquid target; the production is consistent and allows a higher production volume. This new patented process provides a viable alternative for facilities with cyclotrons securing 68Ga access locally and for distribution.”


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