Notaro Anna, Limpido Salvatore, Plougastel Lucie, Zega Alessandro, Telleschi Mauro, Quaglierini Mauro, Danti Alessia, Fiore Antonio, Guiducci Letizia, Poli Michela
CURIUM SPECT Europe (Cis Bio International), CMC Department of R&D, 91400 Saclay, France.
Curium Italy, 20155 Milano, Italy.
Pharmaceuticals (Basel). 2025 May 22;18(6):769. doi: 10.3390/ph18060769.
: Gliomas, including the most aggressive subtype-glioblastoma multiforme, are brain tumors with an unfavorable prognosis and high mortality. Early diagnosis is essential to improve treatment efficacy. Positron emission tomography PET with O-(2-[F] fluoroethyl)-L-tyrosine ([F]FET) has been supported by clinical studies for its role in diagnosis and monitoring the disease. However, the low availability of [F]FET in Italy has limited its use in clinical praxis. This study describes the technological transfer of the radiopharmaceutical IASOglio (the commercial [F]FET developed by Curium Pharma in Italy), with the aim of improving national access to this advanced diagnostic technology. : Three consecutive batches were produced using the automated Trasis AllinOne module, and quality control was performed, including chemical and microbiological tests, to successfully validate the production process. Additionally, the stability of the radiopharmaceutical for its entire shelf life has been demonstrated with stability testing at 14 h after end of synthesis (EOS). : The production of [F]FET achieved a non-corrected yield between 49% and 52%, with a corrected decay rate ranging from 73% to 79%. The process met the required quality specifications, including bio-burden control and filter integrity. The technological transfer was successfully completed, and production authorization was obtained from the Italian Medicines Agency (AIFA) for the Officina Farmaceutica of Institute of Clinical Physiology of the National Research Council (CNR-IFC) located in Pisa. : Local production of [F]FET in Italy marks a milestone in glioma diagnosis, thereby contributing to timely treatment and improved clinical outcomes.
胶质瘤，包括最具侵袭性的亚型——多形性胶质母细胞瘤，是预后不良且死亡率高的脑肿瘤。早期诊断对于提高治疗效果至关重要。采用O-(2-[F]氟乙基)-L-酪氨酸([F]FET)的正电子发射断层扫描(PET)因其在疾病诊断和监测中的作用而得到临床研究的支持。然而，[F]FET在意大利的可及性较低，限制了其在临床实践中的应用。本研究描述了放射性药物IASOglio(由意大利居里制药公司研发的商用[F]FET)的技术转让，目的是改善该国对这种先进诊断技术的获取。连续三批产品使用自动化的Trasis AllinOne模块生产，并进行了质量控制，包括化学和微生物检测，以成功验证生产过程。此外，通过合成结束(EOS)后14小时的稳定性测试，证明了该放射性药物在其整个保质期内的稳定性。[F]FET的生产未校正产率在49%至52%之间，校正后的衰减率在73%至79%之间。该过程符合所需的质量规范，包括生物负荷控制和过滤器完整性。技术转让成功完成，并获得了意大利药品管理局(AIFA)对位于比萨的国家研究委员会临床生理研究所制药厂(CNR-IFC)的生产授权。意大利本地生产[F]FET标志着胶质瘤诊断的一个里程碑，从而有助于及时治疗并改善临床结果。
