色谱法分析重组单克隆抗体电荷异质性应用进展

Progress in application of chromatography for charge heterogeneity of recombinant monoclonal antibodies

无论是电荷,分子量还是其他性质都存在着许多变量,这是单克隆抗体的基本特性。这些电荷变量基本上涉及酸性和碱性。本文概述了能导致一般的酸性和碱性物质及其对抗体结构、稳定性、生物功能等的影响,保证单抗制品生产工艺的稳定性及质量控制。

Charge, molecular weight and other properties have many variables, which are the basic properties of monoclonal antibodies. These charge variants are generally referred to as acidic or basic. This article reviews the effects of general acidic and basic species and their effects on antibody structure, stability and biological functions, to ensure the stability of preparation and quality control for monoclonal antibody.