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 before each injection. The presented FTPFACE approach requires only very small amounts of ligands and provides complete comparability with a standard CZE of a single mAb.
Highlights
A diverse population of charged species in monoclonal antibodies is observed during quality control (QC) of biotechnological pharmaceuticals
We extend the use of flow-through partialfilling affinity capillary electrophoresis (FTPFACE) to the charged heterogeneity profiling of complex monoclonal antibodies (mAbs) mixtures that are considered to be new remedies for complex diseases like cancer [26]
Antibody co-formulations are of increasing importance for the pharmaceutical industry since they turned out to be promising remedies against complex diseases like cancer [26]. This motivates the development of powerful analytical tools that can reliably and address critical quality attributes (CQAs) of these antibody mixtures
Summary
A diverse population of charged species in monoclonal antibodies (mAbs) is observed during quality control (QC) of biotechnological pharmaceuticals. These heterogeneities are caused by enzymatic processes as well as spontaneous chemical events [2]. Health authorities consider charge heterogeneity profiling of biopharmaceuticals as important for product characterization and product stability assessment. For this purpose, different analytical tools for charge heterogeneity profiling, including IEC [4], cIEF [5], and CZE [6] are available. Since these techniques utilize different separation principles, their performance may depend on the individual characteristics of the investigated pharmaceutical and requires a project specific method selection
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