Biologics Development, Bristol-Myers Squibb, Pennington, NJ, USA.
Biologics Development, Bristol-Myers Squibb, Pennington, NJ, USA.
J Chromatogr B Analyt Technol Biomed Life Sci. 2018 Apr 15;1083:271-277. doi: 10.1016/j.jchromb.2018.02.042. Epub 2018 Mar 1.
Product identity is one of the release testing requirements that needs to be established to ensure that there is no misidentification of drugs. Here, we demonstrated the challenges that can come across while establishing a product identity method for monoclonal antibody (mAb) and mAb-related products using icIEF method. A unique three-point identity criteria tool (visual comparison, pI of individual peaks and ΔpIs) was applied to distinguish mAb1 from the other in-house mAbs. A reduction approach followed by icIEF showed higher potential for establishing identity for mAb1 product as compared to native and enzymatic digestion approach. In general, icIEF method lacks specificity required to unequivocally establish the identity for mAbs, therefore, risk analysis is recommended before implementing icIEF as a stand-alone identity method for monoclonal antibodies.
产品标识是放行检测要求之一，需要建立以确保药物不会被错误识别。在这里，我们展示了在使用等电聚焦（icIEF）方法为单克隆抗体（mAb）和 mAb 相关产品建立产品标识方法时可能遇到的挑战。我们应用了独特的三点标识标准工具（视觉比较、各峰等电点和 ΔpIs）来区分 mAb1 与其他内部 mAbs。与天然和酶消化方法相比，还原方法后再进行 icIEF 显示出更高的建立 mAb1 产品标识的潜力。一般来说，icIEF 方法缺乏明确建立 mAbs 标识所需的特异性，因此，建议在将 icIEF 作为单克隆抗体的独立标识方法实施之前进行风险分析。
