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  • Artigo IPEN-doc 30538
    Preliminary study of sterilizing filtration validation
    2024 - OLIVEIRA, V.L.T.; SANTOS, L.J.; CAVALCANTE, L.C.; DIAS, L.A.P.; FELGUEIRAS, C.F.; MATSUDA, M.M.N.
  • Artigo IPEN-doc 27848
    Stability in production and transport of 177Lu labeled PSMA
    2021 - VILLAS BOAS, C.A.W.; DIAS, L.A.P.; MATSUDA, M.M.N.; ARAUJO, E.B.
    In Brazil, prostate cancer is a common disease among men. The radionuclide therapy with PSMA analogs, labeled with beta and alpha emitters, has brought new perspectives for patients with multi metastatic resistant prostate cancer. The commercialization of radiopharmaceutical becomes a challenge to transport and ensure the quality of the product, especially in terms of radiochemical stability of therapeutic radiopharmaceuticals. The effect of radiolysis on therapeutic doses of radiopharmaceuticals can be avoided or mitigated by diluting the final dose and reducing storage and transportation temperature. This study evaluated the effect of radiolysis on the different radioactive concentration in the industrial batches of 177Lu-PSMA-617 and in the fractionated doses, considering long time transportation. The radiopharmaceutical 177Lu-PSMA-617 was produced in batches reaching 37 GBq, and stability studies were performed in controlled conditions. The results showed that a combination of factors, including reaction buffer, the radioactive concentration of final product, and freezing storage contributed to the stability of the radiopharmaceutical for 48 hours, enabling transport of 177Lu-PSMA-617 to distant regions of the country.