ItraPol and LutaPol awarded as Polish product of the future during 17th Annual Competition

ItraPol and LutaPol awarded as Polish product of the future during 17th Annual Competition

LutaPol and ItraPol Radiopharmaceutical  precursors manufactured by the Na­tional Centre for Nuclear Research with use of the modern production line, expand cancer treatment possibilities.

Description of the solution

ItraPol and Lutapol are new medicinal pro­ducts in the radiopharmaceutical precursors category. They contain the radioisotopes 90Y and 177Lu, each in the form of a solution for radiolabelling, indicated for the prepara­tion of radiopharmaceuticals for the internal radiotherapy of cancer.

Both products are precursors of radiophar­maceuticals using specific carrier molecules such as monoclonal antibodies, peptides, etc., intended for internal radiotherapy for a variety of diseases. These radiopharmaceuticals can be prepared in hospital environments accord­ing to EU regulations. Yttrium-90 has a half-life of 2.7 days emitting beta radiation ((3-) with a maximum energy of 2.27 MeV and depth into the tissue about 12 mm. Lutetium-177 has a half-life of 6.7 days emitting (3- radiation with the maximum energy of 0.5 MeV and depth into a tissue around 2 mm. The radiation emit­ted by these two radioisotopes can be used for therapeutic purposes.

These new technologies deliver both radio­pharmaceutical precursors with high chemi­cal and radionuclide purity. The scale of pro­duction ensures their availability for the needs of national nuclear medicine as well as for export.

Novelty of the solution

The market launch of ItraPol and LutaPol me­dicinal products representing the category of radiopharmaceutical precursors, is an ex­ample of product innovation. Novelty of the solution consists in development of techno­logies for manufacturing high quality Yttri­um-90 and Lutetium-177 radiopharmaceutical precursors with high radionuclide and che­mical purity and low level of other radioactive isotopes or ions of other elements. The quality specifications of both precursors meet the pharmaceutical standards that are essential for their safe use in patients. The developed technology of manufacturing ItraPol (90Y) and LutaPol (177Lu) allows to obtain sufficiently high specific activity, the parameter which directly influences the efficacy of treatment. Furthermore, thanks to the implementation of cutting-edge technical solutions, the amount of chemical and radioactive waste has been reduced.

Implementation status

As a part of the implementation of the NCBJ Radioisotope Center POLATOM, a new pro­duction line has been designed and built with a series of specialized and appropriately equipped shielded chambers that meet the standards of the pharmaceutical industry. Already developed work and industrial re­search ensure full production capacity. POLATOM's production is based on their own studies and they intend to start manufacturing of ItraPol and LutaPol using existing facilities.

Implementation benefits

ItraPol and LutaPol are precursors for radio­pharmaceuticals, which are highly specia­lized medicinal products used in the therapy of cancer. Their availability paves the way for development of more effective methods in the fight against cancer. Presented techno­logies allow for commercial scale production. It will also increase the availability of these drugs in the domestic market and contribute to the further dissemination of new methods of internal radiotherapy which in turn will re­sult in the improved quality of life for cancer patients.

Currently, in Poland and the rest of the world, the targeted radiotherapy with the use of synthetic peptides labelled 90Y and 177Lu is applied in the treatment of neuroendocrine tumors. Targeted radiotherapy enables effec­tive medical treatment of individuals whose disease has been resistant to currently applied available therapies. It also allows to combine the effect of different physical characteristics of these isotopes or to combine radiotherapy with the other forms of therapy to destroy the pathologically altered tissue effectively. Scien­tific evidence indicates reduced side effects of targeted radiotherapy of neuroendocrine tumors if compared to chemotherapy. According to the Polish Society of Endocrino­logy, there are 30 cases of cancer (neuroendo­crine tumors) per 1 million people worldwide. This means that 17 thousand people out of 577 million Europeans will suffer from the disease.

Comparison with the current state of the art

The status of radiopharmaceutical precur­sor has only been reached by the product containing Yttrium-90. Only two companies offer this precursor under the trade names of Ytracis and Yttriga. Lutetium-177 chloride has never been granted a status of a radio­pharmaceutical precursor in any country. Po­land is the first country where such status has been reached.

The process line for the production of both precursors
The cross-section of a container used for transporting radioactive material

Products

Our product range includes radiopharmaceuticals, radiochemicals, radioactivity standards and sealed radiation sources. We offer a broad selection of services and workshops, and training.

About Us

National Centre for Nuclear Research, Radioisotope Centre POLATOM is manufacturer and distributor of the isotopic goods applied in medicine, research and development, industry and environment protection.

Certificates

The high professionalism of our company has been confirmed by a number of certificates including GMP for radiopharmaceutical production.