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人用重组单克隆抗体是一种具有复杂的翻译后修饰的生物大分子,其微观不均一性导致单克隆抗体药物并不是单一纯净的物质,而是多种产品相关物质的混合物,因此,对这些产品相关的变体及其降解方式的进一步研究尤为重要。几乎所有变体均能导致抗体表面电荷分布的差异,电荷变量因此成为监测抗体降解最灵敏的方式,也是对产品质量一致性分析的一项重要参考标准。本文对几种主要电荷变体的成因、检测方法及其对产品有效性影响的研究进展作一综述。
Human recombinant mAb is a kind of biological macromolecule with complicated post-translational modification. The microscopic heterogeneity of monoclonal antibody is not a single pure substance, but a mixture of multiple product-related substances. Therefore, Further research on these product-related variants and their ways of degradation is particularly important. Almost all variants lead to differences in the surface charge distribution of antibodies, and thus charge variables are the most sensitive way to monitor antibody degradation and are an important reference for consistent product quality analysis. This article reviewed the research progress of the causes and detection methods of several major charge variants and their impact on product effectiveness.