Babic Ivan, Kesari Santosh, Glassy Mark C
Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, CA, USA.
Translational Neuro-Oncology Laboratory, UCSD Moores Cancer Center, La Jolla, CA, USA.
Methods Mol Biol. 2019;1904:401-415. doi: 10.1007/978-1-4939-8958-4_19.
Pritumumab, a natural human IgG1kappa mAb, was isolated from the regional lymph node of a patient with cervical cancer. This antibody has been reported to bind the cytoskeletal protein vimentin, and to cell surface expressed vimentin referred to as ecto-domain vimentin (EDV). Here, we report details of the development of a potency of binding assay for pritumumab as a prerequisite before pursuing clinical trials. The enzyme linked immunosorbent assay (ELISA) to detect antibody-binding antigen can serve as a potency assay for release of manufactured samples to be used in clinical studies. Several layers of controls for this assay along with suitability testing for reagents and components of the assay must be developed before the assay can be incorporated for stability testing and release of manufatured samples.
普立妥单抗是一种天然人源IgG1κ单克隆抗体，从一名宫颈癌患者的区域淋巴结中分离得到。据报道，该抗体可结合细胞骨架蛋白波形蛋白以及细胞表面表达的波形蛋白（称为胞外域波形蛋白，EDV）。在此，我们报告了普立妥单抗结合活性测定方法开发的详细情况，这是开展临床试验之前的一项先决条件。用于检测抗体结合抗原的酶联免疫吸附测定（ELISA）可作为临床研究中所用生产样品放行的活性测定方法。在将该测定方法用于稳定性测试和生产样品放行之前，必须建立该测定方法的多层对照以及对试剂和测定组件的适用性测试。
