September 3, 2021 — Eckert & Ziegler Radiopharma GmbH has successfully submitted an amendment to their Drug Master File (DMF) to theU.S. Food and Drug AdministrationforGalliaPharm. Their proprietaryGe-68/Ga-68 generatorfrom now on will additionally be available in sizes of up to 100 mCi with a shelf-life of 12 months or for a maximum of 700 elutions. Gallium-68 from GalliaPharm is used for the preparation of diagnostic imaging drugs inPositron Emission Tomography(PET).
“With the development of generators with higher Ge-68 activity and the amendment of our DMF, we are responding to the increasing demand for Ga-68 based diagnostics in the United States,” explained DrHarald Hasselmann, Eckert & Ziegler Executive Director and responsible for the Medical segment. “The soon to be available preparations for imaging of prostate cancer as well as upcoming novel Ga-68 drugs and their theranostic pair, mostly labeled with Lu-177, allow Eckert & Ziegler to strongly support the trend towards higher activity generators and we are currently working to provide comprehensive solutions to the healthcare providers and their patients.”
位于马萨诸塞州威尔明顿的Eckert & Ziegler放射性制药公司总经理Jay Simon补充说:“更高活性的GalliaPharm发生器将使美国各地的核医学机构和放射性制药公司以相同的灵活性准备Ga-68 PET成像产品，同时能够为更多的患者提供程序，并扩大服务范围。”“用户可以从单个发生器洗脱获得额外的剂量，同时能够显著增加每天的洗脱次数。两者都将有助于加强医疗保健，并确保向美国患者提供供应。”
GalliaPharm主要与示踪试剂盒联合用于神经内分泌肿瘤和前列腺癌的诊断。镓发生器为PET中镓-68生物分子的放射标记提供了一种低成本的替代方法，这种成像检查方法用于检测病变组织的存在或不存在。PET成像主要用于癌症、心脏病学或神经学的诊断。氟-18等放射性同位素可以替代使用，但需要对大型设备(回旋加速器)投资数百万美元。另一方面，Ge-68/Ga-68发电机是一种易于运输的小型系统，具有更高的成本效益，为核医学供应商降低成本，同时增加灵活性。
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August 10, 2022
