Volume 6 Issue 2
Apr.  2016
Turn off MathJax
Article Contents
Antonio Martínez-Ortega, Agustín Herrera, Antonio Salmerón-García, José Cabeza, Luis Cuadros-Rodríguez, Natalia Navas. Study and ICH validation of a reverse-phase liquid chromatographic method for the quantification of the intact monoclonal antibody cetuximab$[J]. Journal of Pharmaceutical Analysis, 2016, 6(2): 117-124. doi: 10.1016/j.jpha.2015.11.007
Citation: Antonio Martínez-Ortega, Agustín Herrera, Antonio Salmerón-García, José Cabeza, Luis Cuadros-Rodríguez, Natalia Navas. Study and ICH validation of a reverse-phase liquid chromatographic method for the quantification of the intact monoclonal antibody cetuximab$[J]. Journal of Pharmaceutical Analysis, 2016, 6(2): 117-124. doi: 10.1016/j.jpha.2015.11.007

Study and ICH validation of a reverse-phase liquid chromatographic method for the quantification of the intact monoclonal antibody cetuximab$

doi: 10.1016/j.jpha.2015.11.007
  • Publish Date: Apr. 10, 2016
  • Cetuximab (CTX) is a potent chimeric mouse/human monoclonal antibody (mAb) approved worldwide for treatment of metastatic colorectal cancer. Among the various biological and physical analyses per-formed for full study on this biopharmaceutic, the determination of the concentration preparations throughout manufacturing and subsequent handling in hospital is particularly relevant. In the present work, the study and validation of a method for quantifying intact CTX by reverse-phase high-perfor-mance liquid chromatography with diode array detection ((RP)HPLC/DAD) is presented. With that end, we checked the performance of a chromatographic method for quantifying CTX and conducted a study to validate the method as stability-indicating in accordance with the International Conference on Harmo-nization guidelines (ICH) for biotechnological drugs; therefore, we evaluated linearity, accuracy, preci-sion, detection and quantification limits, robustness and system suitability. The specificity of the method and the robustness of the mAb formulation against external stress factors were estimated by compre-hensive chromatographic analysis by subjecting CTX to several informative stress conditions. As de-monstrated, the method is rapid, accurate, and reproducible for CTX quantification. It was also suc-cessfully used to quantify CTX in a long-term stability study performed under hospital conditions.
  • loading
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Article Metrics

    Article views (25) PDF downloads(0) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return