Production and Quality Control of Yttrium-90 Resin Microspheres for Radioembolization of Liver Cancer

Document Type : Original Article

Authors

1 Radiation Applications Research School, Nuclear Science and Technology Research Institute (NSTRI), AEOI, Tehran, Iran

2 Radiation Application Research School, Nuclear Science and Technology Research Institute, Tehran, Iran.

10.22052/rsm.2025.256988.1131

Abstract

Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and one of the leading causes of cancer-related mortality worldwide. Due to limitations associated with liver transplantation and surgical resection, radioembolization using yttrium-90 (Y-90) microspheres has gained attention as an effective locoregional treatment. In this study, Y-90 resin microspheres were prepared using Dowex 1×8 ion-exchange resin, and a comprehensive quality control assessment was performed. The final product demonstrated a high radiochemical purity exceeding 99%, a labeling efficiency over 92%, and excellent stability, with purity remaining above 98% after 48 hours. Moreover, sterility, endotoxin levels, and particle size distribution were all within the acceptable limits defined by international pharmacopeia standards. The use of Dowex resin, known for its affordability, availability, and favorable ion-exchange capacity, provided a simple and efficient platform for microsphere preparation. The results indicate that the formulated Y-90 microspheres meet clinical-grade criteria and hold significant potential for application in selective internal radiation therapy (SIRT) of liver cancers. This approach offers a cost-effective and scalable strategy for domestic production of therapeutic radiopharmaceuticals and represents a valuable step toward self-sufficiency in treating advanced liver tumors.

Keywords

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