@article{Sammartano_Migliari_Scarlattei_Baldari_Ruffini_2020, title={Synthesis, validation and quality controls of [68Ga]-DOTA-Pentixafor for PET imaging of chemokine receptor CXCR4 expression: Synthesis and CQ of [68Ga]-DOTA-Pentixafor}, volume={91}, url={https://mattioli1885journals.com/index.php/actabiomedica/article/view/9106}, DOI={10.23750/abm.v91i4.9106}, abstractNote={<p><em><strong>Background.</strong></em> Chemokine receptor-4 (CXCR4) is involved in tumor growth and progression in several types of human cancer.</p> <p>Recently, [<sup>68</sup>Ga]-DOTA-Pentixafor has been assessed as an excellent imaging probe targeting CXCR4-expression using positron emission tomography (PET).</p> <p>Here we report on the entire production cycle of [<sup>68</sup>Ga]-DOTA-Pentixafor, including quality control development and process validation.</p> <p><strong><em>Methods.</em></strong> Synthesis of [<sup>68</sup>Ga]-DOTA-Pentixafor was validated <em>via </em>three independent and consecutive production runs using an automated synthesis system. All validation runs must pass the pre-set quality control (QC) limits. Validation was performed for established QC tests to ensure that methods were reproducible and reliable in routine use. Germanium-68 breakthrough was determined for each sample<sub>. </sub>Production yield was calculated for each synthesis to assess the performance and efficiency of the radiolabeling process. The quality of the final product<em> was </em>determined by ITLC and HPLC methods after each synthesis.</p> <p><strong><em>Results</em></strong><strong><em>.</em></strong> The average ITLC‐measured radiochemical purity was above 98.5% and HPLC‐measured radiochemical purity was 99.86%, 99,83% and 100% in the three validation runs. Germanium breakthrough was 4.8*10-5%, 4.9*10-5% and 4.7*10-5% of total activity, far below the recommended level of 0.001%. Residual ethanol resulted 5.22%, 5.58% and 5.32%V/V; spot of HEPES impurity was not more intense than spot of reference solution (200µg/V). Endotoxin level resulted <17.5EU/ml. <em>pH</em> of the final product was 7 in all samples.</p> <p><strong>Conclusion: </strong>[<sup>68</sup>Ga]-DOTA-Pentixafor fit requirements of the pre-set quality parameters of purity, efficacy and safety in the batches considered for this study  and fulfilled all the acceptance criteria for injectable radiopharmaceutical products. The results demonstrated a batch-to-batch reproducibility providing high radiochemical purity.</p>}, number={4}, journal={Acta Biomedica Atenei Parmensis}, author={Sammartano, Antonino and Migliari, Silvia and Scarlattei, Maura and Baldari, Giorgio and Ruffini, Livia}, year={2020}, month={Jul.}, pages={e2020097} }