See II.2.4
Purpose of services: Industrial scaling of bulk processing and column filling for radiopharmaceutical generators.
IRE ELit is one of only two global suppliers of Germanium-68 (68Ge)/gallium-68 (68Ga) generators to have been approved as a drug in Europe and as an active pharmaceutical ingredient in the United States. The radionuclide generator is a system for eluting gallium chloride (68Ga) solution for radiolabeling. This solution is eluted from a column to which the germanium-68 mother nuclide (68Ge), which is the parent of gallium-68 (68Ga), is fixed to a titanium dioxide sorbent.
More information on the characteristics of the Elit Elit Germanium-68 (68Ge) /gallium-68 (68Ga) radionuclide generator is available at https://www.ire.eu/medias/295/UK.pdf.
With a view to increasing its production capacity, IRE Elit intends to intensify the preparation of titanium dioxide columns in Germanium-68 (68Ge) /gallium-68 (68Ga) generators. This contract notice concerns the scaling of titanium dioxide treatment and its filling in the column. Interested candidates will have to justify their experience in the field (experience with similar projects/products, access to appropriate technologies/equipment).
The objective of this innovation project is to optimize the processing and packaging of titanium dioxide and to transfer technology that is ready to be scaled up. The final deliverables that will be expected of the bidder are:
- a detailed development report summarizing the analyses performed to optimize the processing and packaging of titanium dioxide, including identification of critical process parameters, evidence regarding the reproducibility of the optimized process and evidence regarding the stability of the treated mass
- optimized process procedures
- a detailed description of the design of the equipment to be used for scaling.
All intellectual property rights relating to software, hardware, designs, plans, studies, know-how, etc. that the tenderer provides to the contracting authority in execution of this contract shall belong exclusively to the contracting authority. In the event that the tenderer holds pre-existing intellectual property rights useful or necessary for the exploitation of the results, the tenderer will grant a licence to the contracting authority for the sole purpose of enabling the contracting authority to exploit the results.