Application of affinity capillary electrophoresis for charge heterogeneity profiling of biopharmaceuticals.

ABSTRACT: Charge heterogeneity profiling is important for the quality control (QC) of biopharmaceuticals. Because of the increasing complexity of these therapeutic entities [1], the development of alternative analytical techniques is needed. In this work, flow-through partial-filling affinity capillary electrophoresis (FTPFACE) has been established as a method for the analysis of a mixture of two similar monoclonal antibodies (mAbs). The addition of a specific ligand results in the complexation of one mAb in the co-formulation, thus changing its migration time in the electric field. This allows the characterization of the charged variants of the non-shifted mAb without interferences. Adsorption of proteins to the inner capillary wall has been circumvented by rinsing with guanidine hydrochloride befo

SUBMITTER: Hutanu A 

PROVIDER: S-EPMC6900010 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature