Biopharmaceuticals (recombinant technology-based products, vaccines, whole blood and blood components, gene therapy, cells, tissues, etc.,) are described as biological medical products produced from various living sources such as human, microbial, animal, and so on by manufacturing, extraction, or semi-synthesis. They are complex molecules having high molecular weights. For their safety and efficacy, their structural, clinical, physicochemical, and chemical features must be carefully controlled, and they must be well characterized by analytical techniques before the approval of the final product. Capillary electrophoresis (CE) having versatile modes can provide valuable safety and efficacy information, such as amino acid sequence, size variants (low and high molecular weight variants), charged variants (acidic and basic impurities), aggregates, N-linked glycosylation, and O-linked glycosylation. There are numerous applications of CE in the literature. In this review, the most significant and recent studies on the analysis of recombinant DNA technology-based products using different CE modes in the last ten years have been overviewed. It was seen that the researches mostly focus on the analysis of mAbs and IgG. In addition, in recent years, researchers have started to prefer CE combined mass spectrometry (MS) techniques to provide a more detailed characterization for protein and peptide fragments.

中文翻译：

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毛细管电泳方法在基于重组 DNA 技术的产品上的最新生物制药应用

生物制药（基于重组​​技术的产品、疫苗、全血和血液成分、基因治疗、细胞、组织等）被描述为从人类、微生物、动物等各种生命来源生产的生物医药产品制造、提取或半合成。它们是具有高分子量的复杂分子。为了它们的安全性和有效性，它们的结构、临床、理化和化学特性必须仔细控制，并且在最终产品批准之前必须通过分析技术对其进行很好的表征。具有多种模式的毛细管电泳 (CE) 可以提供有价值的安全性和有效性信息，例如氨基酸序列、大小变异体（低分子量和高分子量变异体）、带电变异体（酸性和碱性杂质）、聚集体、N-连接糖基化和O-连接糖基化。文献中有许多 CE 的应用。在这篇综述中，概述了过去十年中使用不同 CE 模式分析基于重组 DNA 技术的产品的最重要和最近的研究。可以看出，研究主要集中在 mAbs 和 IgG 的分析上。此外，近年来，研究人员开始更喜欢 CE 组合质谱 (MS) 技术，以提供更详细的蛋白质和肽片段表征。