This study aimed to establish a second national standard for hepatitis B immunoglobulin (HBIG) that can be used for potency assays of hepatitis B and normal immunoglobulin. The candidate material was manufactured using a process approved as Good Manufacturing Practice. The freeze-dried candidate preparation was tested for physicochemical and biological properties, including pH, residual moisture, molecular size distribution, and potency. A collaborative study was performed involving four laboratories, including the National Institute of Food and Drug Safety Evaluation, as an official national control laboratory in Korea and manufacturers. The potency was calibrated against the second international standard for HBIG using two enzyme immunoassays: enzyme-linked immunosorbent assay and electrochemiluminescence immunoassay. Results from 240 assays were obtained from four laboratories, and combined potency estimates were obtained by calculating the geometric means. Intra- and inter-laboratory variability showed acceptable geometric coefficients of variation of 1.3–6.0 and 3.2–3.6%, respectively. The candidate preparation showed satisfactory stability in accelerated thermal degradation and real-time stability tests. Based on these results, the potency value of 105 IU/vial was assigned (95% confidence intervals: 100.0–109.2 IU/vial), and it was deemed suitable to serve as the Korean national standard for HBIG.

本研究旨在建立乙型肝炎免疫球蛋白（HBIG）的第二个国家标准，可用于乙型肝炎和正常免疫球蛋白的效价测定。候选材料是使用批准为良好生产规范的工艺制造的。对冷冻干燥的候选制剂进行了理化和生物学特性测试，包括 pH 值、残留水分、分子大小分布和效力。一项合作研究涉及四个实验室，包括作为韩国官方国家控制实验室的国家食品药品安全评估研究所和制造商。使用两种酶免疫测定法根据 HBIG 的第二个国际标准校准效力：酶联免疫吸附测定法和电化学发光免疫测定法。从四个实验室获得了 240 次检测的结果，并通过计算几何平均值获得了综合效力估计值。实验室内和实验室间变异性显示可接受的几何变异系数分别为 1.3-6.0 和 3.2-3.6%。候选制剂在加速热降解和实时稳定性测试中表现出令人满意的稳定性。基于这些结果，指定了 105 IU/瓶的效力值（95% 置信区间：100.0–109.2 IU/瓶），并被认为适合作为 HBIG 的韩国国家标准。候选制剂在加速热降解和实时稳定性测试中表现出令人满意的稳定性。基于这些结果，指定了 105 IU/瓶的效力值（95% 置信区间：100.0–109.2 IU/瓶），并被认为适合作为 HBIG 的韩国国家标准。候选制剂在加速热降解和实时稳定性测试中表现出令人满意的稳定性。基于这些结果，指定了 105 IU/瓶的效力值（95% 置信区间：100.0–109.2 IU/瓶），并被认为适合作为 HBIG 的韩国国家标准。