A three-point identity criteria tool for establishing product identity using icIEF method.

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.