Complementary Methodologies To Optimize Monoclonal Antibody Analysis
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Size heterogeneity is a critical quality attribute (CQA) of monoclonal antibodies (mAb), as both aggregation and degradation can impact the safety and efficacy of therapeutic antibodies.
Regulatory compliance requires advanced methodologies to assess these CQAs effectively. One example is the use of size exclusion chromatography (SEC) and capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) for comprehensive impurity analysis.
This application note explores how these complementary techniques provide unique insights into size heterogeneity, offering a clearer picture of antibody integrity.
Download this application note to discover:
- Insights into method selection for precise impurity quantification
- Key advantage of SEC and CE-SDS for mAb monomeric purity
- How combining these techniques improves mAb analysis
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