90Y, a radionuclide well suited for endoradiotherapy, is distributed from specialized production sites where stocks of 90Sr are routinely processed. The state of the art of 90Sr/90Y separation technology is not really applicable to hospitals for safety reasons, thus a large portion of the costs of 90Y therapy comes from transportation. New technologies are needed in order to provide the possibility of local distribution of 90Y from remotely operated generator systems, making this therapeutic agent available at more competitive price.
The separation procedure typically lasts for 60 min and the final product is formulated in 0.05 M HCl having a total volume from 0.25 to 2.0 ml. The vial with the product can be autoclaved and the preparation is suitable for labeling monoclonal antibodies and peptides. Depending on the activity concentration of the stock solution of 90Sr, batch sizes of 37 GBq 90Y can be made available on daily basis. The most critical quality factor of 90Y is its contamination with 90Sr. The technical solution allows producing the 90Y in the quality parameters required from the pharmacopoeia.
Electrochemical separation of 86Sr/86Y is nowadays well established and used for the production of 86Y. The same basic principle has been applied in developing an automated generator for daily 90Y supply. The generator consists of a shielded reservoir containing a stock solution of 90Sr of high purity, being in transient equilibrium with 90Y. A fraction of this stock solution is transferred to the electrochemical cell, where a two step separation is performed using platinum electrodes. After the separation the solution from the electrochemical cell is transferred back to the stock solution maintaining the total 90Sr inventory practically constant. Due to the fact that only a portion of the stock solution is processed one can milk the generator every day providing practically the same yield day after day.
The operation of the generator is completely automated and computer controlled and it is suitable for installation in general purpose hotcell. Operators are required only to insert the empty and to remove the vial with the product from the hotcell and to replace the sterile filters prior to milking the generator. Small amounts of 90Sr lost during the washing procedures are collected in a dedicated reservoir and can be recovered from time to time if required.
The newly developed 90Sr/90Y generator allows for daily production of 37 GBq 90Y batches and local distribution from specializedregional centers. Widespread use of this
technology could bring targeted radioimmunotherapy to a significantly larger
number of patients even in developing countries.
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