单克隆抗体药物质量控制及HPLC分析技术

BioAssist系列色谱柱对单克隆抗体的分离分析

   2014-08-19
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Abstract
TSKgel BioAssist S columns are eminently suitable for analysis of monoclonal antibodies at pH 6.0 where their stability is least affected. Similar high resolution analysis of monoclonal antibodies is possible for negatively charged antibodies on TSKgel BioAssist Q columns at pH 8.0.

Introduction
The challenge in developing an ion exchange packing material for analyzing biopolymers is to design particles that contain large pores and have high binding capacity. Although large pores may allow full access to the available interior surface area of a particle, a simple monomeric bonded phase, as is commonly used for analyzing small molecular weight compounds, would neither result in sufficient solute retention nor in appreciable binding capacity. It has been shown1 that so-called tentacle-type stationary phases can significantly increase the number of available binding sites, and thus binding capacity, by creating a polymer with multiple functional groups. The disadvantage of this approach is that the polymer, in turn, reduces the effective pore size. Tosoh researchers have developed crosslinked polymeric phases on large pore size particles that result in a minimal reduction of the effective pore size, while maintaining high binding capacities independent of protein molecular weight. This application note demonstrates the benefits of such materials for the analysis of monoclonal antibodies by cation and anion exchange chromatography.

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编辑: gaowei2010    来源:丁香园