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.

产品标识是必须建立的释放测试要求之一，以确保没有错误标识药物。在这里，我们展示了在使用icIEF方法建立单克隆抗体（mAb）和mAb相关产品的产品标识方法时可能遇到的挑战。应用了独特的三点身份标准工具（视觉比较，单个峰的pI和ΔpIs）来区分mAb1与其他内部mAb。与天然和酶消化方法相比，采用icIEF的还原方法显示出建立mAb1产品同一性的更高潜力。通常，icIEF方法缺乏明确建立mAb身份所需的特异性，因此，