Authorisation has been given by the local German competent authority as well as by the US FDA
Production line for low-level radioactive sources against cancer
Eckert & Ziegler has been given the manufacturing authorisation for additional production lines for its Ge-68/Ga-68-generators (GalliaPharm(R)). The authorisation has been given by the local German competent authority as well as by the US Food and Drug Administration (FDA).
Both acceptances were made without any major restrictions or reservations. The additional capacities are available immediately.
Due to supply bottlenecks in summer 2018, the isotope specialist invested in its production capacity for the highly demanded raw material Ga-68 for precision oncology last year and announced an expansion of capacity.
The manufacturing licence has now been issued as planned on 23 August 2019 by the US FDA and previously by the Berlin State Office for Health and Welfare.
"We are pleased to have passed this milestone and now feel prepared for the surge in demand, which could show up in the coming year with successful completion of various clinical developments. At the moment, there are half a dozen radiopharmaceuticals from international pharmaceutical companies in advanced clinical trials, including major indications such as prostate cancer," explains Dr Lutz Helmke, member of the Executive Board of Eckert & Ziegler AG and responsible for the Radiopharma segment.
Ge-68/Ga-68-generators enable Gallium-68 radionuclide production for use in Positron Emission Tomography (PET). The radionuclide can be coupled with a multipurpose diagnostic biomolecule to locally create ready-for-use pharmaceuticals used in PET scan diagnoses. Currently, Gallium-68 labelled diagnostic pharmaceuticals are mostly used in precision oncology, in which the radiopharmaceutical is injected into the patient and binds to the tumour cell.
In contrast to Fluorine-18 or Carbon-11 based PET diagnostics, Gallium-68 based technology does not require the use of expensive cyclotrons, thereby reducing costs and enabling increased flexibility in the practice of nuclear medicine diagnostic imaging.