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目的比较3种方法定量检测抗体样品的异同,为抗体药物研发和生产过程中不同类型的样品定量检测选择合适的方法提供依据。方法分别利用生物膜干涉技术、Protein G-HPLC以及双抗体夹心ELISA法建立定量检测抗体样品的方法,比较其检测的准确度、精密度及其检测特点。结果 3种方法检测同一抗体样品的含量基本一致,生物膜干涉技术检测值相对标准偏差最小(CV<5%),HPLC次之(CV<8%),ELISA法的CV值为5%~15%。结论生物膜干涉技术检测快速,结果精确,通量高,无需样品前处理,适合于样品筛选以及发酵原液、中间品等检测;Protein G-HPLC检测准确,线性范围宽,回收率高,认可度高,适合于样品含量的确证;ELISA法最低检测限值小,操作简单,仪器要求低,适合于微量样品的检测。
OBJECTIVE To compare the similarities and differences between the three methods for the quantitative detection of antibody samples and to provide a basis for the selection of suitable methods for the quantitative detection of different types of samples in the course of antibody drug development and production. Methods The biofilm interference technique, Protein G-HPLC and double antibody sandwich ELISA were used to establish the method of quantitative detection of antibody samples. The accuracy, precision and detection characteristics of the antibody were compared. Results The relative standard deviations (CV <5%) of biofilm interference were the lowest (CV <8%). The CV of ELISA was 5% ~ 15 %. Conclusions Biofilm interferometry has the advantages of fast detection, accurate results, high throughput, no sample preparation, suitable for sample screening, detection of fermentation raw materials and intermediate products, accurate protein G-HPLC detection, wide linear range, high recovery rate, High, suitable for the confirmation of the sample content; ELISA minimum detection limit is small, simple operation, low instrument requirements for the detection of trace samples.