Abstract
Therapeutic monoclonal antibodies (mAbs) are dominating the biopharmaceutical field due to the fact of their high specificity in the treatment of diverse diseases. Nevertheless, mAbs are very complex glycoproteins exhibiting several macro- and microheterogeneities that may affect their safety, quality, and efficacy. This complexity is very challenging for mAbs development, formulation, and quality control. To tackle the quality issue, a combination of multiple analytical approaches is necessary. In this perspective, capillary electrophoresis has gained considerable interest over the last decade due to the fact of its complementary features to chromatographic approaches. This review provides an overview of the strategies of mAbs and derivatives analysis by capillary electrophoresis hyphenated to ultraviolet, fluorescence, and mass spectrometry detection. The main sample preparation approaches used for mAb analytical characterization (i.e., intact, middle-up/down, and bottom-up) are detailed. The different electrophoretic modes used as well as integrated analysis approaches (sample preparation and separation) are critically discussed.
Highlights
Therapeutic monoclonal antibodies target antigens and have proven their efficacy in many human diseases, especially autoimmune diseases, cancers
Zhu et al reported the analyses of host cell proteins (HCP). monoclonal antibodies (mAbs) were depleted using protein A/L columns, HCPs were digested with trypsin and isotopic-labeled peptides were incorporated in the sample prepared in 0.05% formic acid with 25% acetonitrile solution to allow stacking before analysis by Capillary Zone Electrophoresis (CZE)– ESI–mass sp (MS)/MS with 0.1% formic acid background electrolyte (BGE) [142]
Capillary electrophoresis has become a powerful technique for mAbs analyses at different steps of their development from clone selection to batch release
Summary
Therapeutic monoclonal antibodies (mAbs) target antigens and have proven their efficacy in many human diseases, especially autoimmune diseases (rheumatoid arthritis, lupus, psoriasis, inflammatory bowel diseases), cancers (breast, lung, colorectal, and hematological cancers) Their humanization has greatly enhanced their biocompatibility and decreased their side effects such as immunogenicity. Monoclonal antibodies formulations usually contain mAbs at high concentrations (10 to 100 g/L), buffers (e.g., phosphate, citrate, acetate), salts (e.g., sodium chloride), and excipients (e.g., sucrose, trehalose, polysorbate 80) at relatively high concentrations [16]. These latter components ensure the stability of the formulation [17]. Other considerations relatives to specific approaches, electrophoretic techniques, and MS are discussed below
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