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目的:考察不同取样方式对光阻法检测小装量治疗性抗体不溶性微粒的影响。方法:采用光阻法对体积小于25 m L的19个靶点65个批次治疗性抗体中≥2μm、≥10μm和≥25μm的不溶性微粒进行检测,将抗体分为3组,取样方式分别为单支样品不同取样体积(0.5、1、3 m L)检测与合并样品(取样体积5 m L)检测,合并样品不同取样体积(0.5、1、3、5 m L)检测,以及合并样品后稀释(稀释20、10、5倍)检测与合并样品原倍检测。结果:对于≥2μm、≥10μm、≥25μm的不溶性微粒,不管是采用单支样品不同取样体积还是采用合并样品后不同取样体积,与合并样品后每次取样5 m L的不溶性微粒检测结果相比,均没有统计学意义上的差异;且≥2μm不溶性微粒的取样体积变异小于≥10μm、≥25μm的不溶性微粒。合并样品后稀释检测的结果则与合并样品检测的结果具有统计学差异,且稀释后的结果要高于未稀释的结果,稀释倍数越大,与未稀释结果的差异也越大。结论:采用光阻法对体积小于25 m L的小装量治疗性抗体进行不溶性微粒检测时,为节省样品并减少外源微粒污染,不管单支取样还是合并取样,均可首先考虑选择小于5 m L的单次取样体积进行检测,而对合并后稀释检测的方式应慎重选择。
OBJECTIVE: To investigate the effect of different sampling methods on the detection of insoluble particles by a small volume of therapeutic antibody by photoplethysmography. Methods: Photoluminescence was used to detect insoluble microparticles of ≥2μm, ≥10μm and ≥25μm in 65 batches of therapeutic antibodies of 19 targets with volume less than 25 m L. The antibodies were divided into three groups and the sampling methods were (0.5, 1, 3 mL) for single sample and 5 mL for the combined samples (0.5, 1, 3, 5 mL), as well as the combined samples for different sample volumes Dilution (diluted 20,10,5 times) detection and merger sample times the original test. Results: For insoluble particles ≥2μm, ≥10μm and ≥25μm, no matter using different sampling volume of single sample or different sampling volume after combining samples, compared with the result of insoluble particles detection of 5 mL per sample after sampling , No statistically significant difference; and ≥ 2μm insoluble particles sampling volume variation is less than ≥ 10μm, ≥ 25μm insoluble particles. The result of the combined sample dilution test is statistically different from the combined sample test result, and the diluted result is higher than the undiluted result. The greater the dilution ratio, the greater the difference with the undiluted result. CONCLUSIONS: When using light-blocking method to detect insoluble particles in cuvettes with therapeutic volume of less than 25 m L, in order to save samples and reduce foreign particles pollution, no matter whether single sampling or combined sampling, the first choice is less than 5 m L single sample volume to be tested, and the combined dilution test should be carefully selected.