The assay of Anti T lymphocyte immunoglobulin for final drug product testing is carried out using flow cytometry on Peripheral Blood Mononuclear Cells (PBMCs) as specified in European and British Pharmacopeia. An alternate assay was developed wherein the potency based quality control evaluation of Anti T lymphocyte immunoglobulin is carried out by measuring complement dependent cytotoxicity (CDC) using fluorescent resazurin dye. The reported bioassay was specific, linear (R² = 0.98), precise (%GCV for repeatability was 3.54% and intermediate precision was 4.27%) and accurate with relative bias of −5.54%. On the basis of results obtained from the repeated performances on single available product, system suitability criteria and sample acceptance criteria were proposed wherein Slope from 4 PL curve fit results for Reference Standard (RS) should be > 0.9, EC₅₀ for RS should lie between 0.264 and 1.131 μg/ml and fold response should be > 2. Confidence interval range and estimated relative potency range obtained from the method validation were narrower than those mentioned for compendial method.

如欧洲和英国药典所述，使用流式细胞术在外周血单核细胞（PBMC）上进行抗T淋巴细胞免疫球蛋白最终产品测试的分析。开发了另一种测定法，其中通过使用荧光刃天青素染料测量补体依赖性细胞毒性（CDC）来进行抗T淋巴细胞免疫球蛋白的基于效能的质量控制评估。报道的生物测定是特异性的，线性的（R ² = 0.98），精确度（可重复性的％GCV为3.54％，中间精度为4.27％）和相对偏差为-5.54％的精确度。根据在单个产品上的重复性能获得的结果，提出了系统适用性标准和样品接受标准，其中参考标准（RS）的4 PL曲线拟合结果的斜率应> 0.9，RS的EC ₅₀应介于0.264和1.131μg/ ml，倍数响应应>2。方法验证获得的置信区间范围和估计的相对效价范围要比药典方法窄。