Impact of linker-drug on ion exchange chromatography separation of antibody-drug conjugates.

ABSTRACT: Charge variants are important attributes of monoclonal antibodies, including antibody-drug conjugates (ADCs), because charge variants can potentially influence the stability and biological activity of these molecules. Ion exchange chromatography (IEX) is widely used for charge variants analysis of mAbs and offers the feasibility of fractionation for in-depth characterization. However, the conjugated linker-drug on ADCs could potentially affect the separation performance of IEX, considering IEX separation relies on surface charge distribution of analyte and involves the interaction between analyte surface and IEX stationary phase. Here, we investigated weak cation exchange chromatography (WCX) for its application in analyzing three ADCs (two broad distribution ADCs and an ADC with controlle

SUBMITTER: Zhang Z 

PROVIDER: S-EPMC6748606 | biostudies-literature | 2019 Aug/Sep

REPOSITORIES: biostudies-literature