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The efficacy and safety of mAbs is ensured by tightly controlled critical quality attributes (CQA) such as the charge heterogeneity. To monitor the CQAs of mAbs, sensitive and reliable analytical methods are essential. This application note demonstrates the successful charge heterogeneity analysis of an IgG4-based mAb with a pI of 6.6 using a strong anion exchange column, BioPro IEX QF, coupled to mass spectrometry (MS) detection. PNGase F-mediated deglycosylation enhanced the resolution of glycosylated variants, allowing for precise monitoring of Fc CQAs.
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ILM 51.6 Sept 2026
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