Evaluation of the 177mLu-concentration in in-house produced 177Lu-radiopharmaceuticals and commercially available Lutathera®

IF 4.4 Q1 CHEMISTRY, INORGANIC & NUCLEAR EJNMMI Radiopharmacy and Chemistry Pub Date : 2023-11-06 DOI:10.1186/s41181-023-00222-2

Matthias Balzer, Fleur Spiecker, Stephanie Bluemel, Holger Amthauer, Winfried Brenner, Sarah Spreckelmeyer

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Abstract

Background

¹⁷⁷Lu-radiopharmaceuticals can contain the metastable impurity [^177mLu]lutetium with a physical half-life of 160.4 days, in varying concentrations depending on the route of production of the radionuclidic precursor [¹⁷⁷Lu]lutetium. Due to the long half-life of [^177mLu]lutetium, difficulties with waste disposal or sterility testing could arise. Here, we analyzed several ¹⁷⁷Lu-samples of different origins and suppliers regarding their ^177mLu-concentration.

Results

All samples tested showed a ^177mLu-concentration in the range that was stated on the certificate of analysis from the supplier which is in accordance with the European Pharmacopoeia.

Conclusions

Although all ^177mLu-concentrations were in accordance with the European Pharmacopoeia, we need to take into account the respective national legislation regarding radioactivity release limits. With regard to the German legislation, several probes for sterility testing in external laboratories could not be released for transport due to the concentration of [^177mLu]lutetium. Moreover, waste water tanks should specifically be monitored for ^177mLu-concentration, when e.g. Lutathera^® is administered in the clinic.

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内部生产的177Lu放射性药物和市售Luthathera®中177mLu浓度的评估。

背景：177Lu放射性药物可能含有物理半衰期为160.4天的亚稳态杂质[177mLu]镥，其浓度不同，取决于放射性核素前体[177Lu]镥的生产途径。由于[177mLu]镥的半衰期较长，可能会出现废物处理或无菌检测方面的困难。在这里我们分析了几个不同来源和供应商的177Lu样品的177mLu浓度。结果：所有测试样品的177mL u浓度均在供应商的分析证书上规定的范围内，该证书符合《欧洲药典》，我们需要考虑到各国关于放射性释放限制的立法。关于德国立法，由于[177mLu]镥的浓度，在外部实验室进行无菌检测的几种探针无法放行运输。此外，当在诊所使用Luthathera®时，应特别监测废水罐的177毫升u浓度。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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