单克隆抗体中电荷异质性分析检测方案(毛细管电泳仪)

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Monoclonal Antibody ChargeHeterogeneity AAnalysisbyCZE andCZE/MS comparison of charge variantprofiless ofRituximab Innovator and Biosimilar mAbs Introduction： During biosysnthesis，various post-translational modifi cations (PTMs)will lead tocharge heterogeneity in monoclonal antibody(mAb)products.Due to these modifications. charge variants can affect the biologicalpropertiesof mAbs asbiotherapeutics. Hence it is very important to monitor this quality attribute duringbioprocessing for lot-to-lot consistency and stability. Capillary electrophoresis (CE)with charge to mass based separation mechanism， is best situated for separation ofcharged molecules.. DDue to difference in net charge of the charge variants，theirelectrophoretic mobility differs， resulting in capillary zone electrophoresis (CZE)separation1，2. This Application Note demonstrates the feasibility of using CZE formonitoring the charge variants of innovator and biosimilar rituximab on Agilent 7100CE system. Further. thebasic chargevariants offbiosimilar rituximab werecharacterized by CZE/MS. . Agilent Technologies During biosysnthesis, various post-translational modifi cations (PTMs) will lead to charge heterogeneity in monoclonal antibody (mAb) products. Due to these modifi cations, charge variants can affect the biological properties of mAbs as biotherapeutics. Hence it is very important to monitor this quality attribute during bioprocessing for lot-to-lot consistency and stability. Capillary electrophoresis (CE) with charge to mass based separation mechanism, is best situated for separation of charged molecules. Due to difference in net charge of the charge variants, their electrophoretic mobility differs, resulting in capillary zone electrophoresis (CZE) separation1,2. This Application Note demonstrates the feasibility of using CZE for monitoring the charge variants of innovator and biosimilar rituximab on Agilent 7100 CE system. Further, the basic charge variants of biosimilar rituximab were characterized by CZE/MS.