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Background and Importance 177Lu-PSMA-617 is a treatment of progressive, metastatic, castration-resistant prostate cancers expressing PSMA receptors, previously treated with taxane and at least one second-generation hormone therapy. 177Lu-PSMA-617 is a radiopharmaceutical drug with a marketing authorisation and is manufactured industrially (PLUVICTO®, Novartis). However, it can also be prepared in-house, especially for preclinical applications. Thus, quality control procedures are required to determine radiochemical purity (RCP). Aim and Objectives To develop and validate a radio-high-performance liquid chromatography (HPLC) analysis method to measure RCP of 177Lu-PSMA-617. Material and Methods Radio-HPLC analyses were carried out on an apparatus equipped with a C18 column and a radioactivity detector. Three commercial 177Lu-PSMA-617 batches were used as samples. The parameters considered for method validation were specificity, linearity, accuracy, precision, robustness, limits of detection (LOD) and limits of quantification (LOQ). Means, standard deviations and coefficient of variation (CV) for RCP, retention time (tr) and recovery were calculated. Linear regression coefficient R2 was computed for linearity. Results Radiochemical identification of 177Lu-PSMA-617 consisted in 10 analyses of each three commercial batches and showed a consistent tr of 10.07 min (CV% 2 = 0.9977). Robustness was found to be limited as the mean tr values varied by -4.8% when the column was heated to 50 °C instead of 25 °C. Conclusion and Relevance A radio-HPLC method for the quality control of 177Lu-PSMA-617 was validated and can be used for in-house preparations for preclinical purposes of this radioactive drug. References and/or Acknowledgements Conflict of Interest No conflict of interest.
Salle et al. (Fri,) studied this question.