Monoclonal Antibodies (MAbs) make up the dominant portion of therapeutic proteins, the fastest growing segment of global pharmaceutical production. These complex molecules require accurate characterization of product purity, heterogeneity and identity. This includes data regarding their stability, shelf life and related manufacturing processes. For characterizing MAbs in an analytical development and QA/QC environment, you need:
Automated, qualitative and quantitative analyses
Simplified functionality and maximum operational efficiency
Robust, validated applications that can be transferred globally across your entire organization and contract manufacturing partners
High Resolution, Automated, Quantitative Protein Purity Analysis with SDS-Gel Capillary Electrophoresis
The PA 800 Plus Pharmaceutical Analysis System enables you to automate size separation of MAbs and provides you with high-resolution, reproducible and quantitative data in place of traditional labor-intensive SDS slab gel electrophoresis.
The PA 800 Plus IgG Purity and Heterogeneity chemistry has become the gold standard for MAb purity analysis in biopharmaceutical and CRO laboratories alike. It is no surprise then, that this CE SDS-gel based method has been successfully implemented by different organizations in various locations with high precision. Portability of the IgG Purity and Heterogeneity Assay was demonstrated and published in a study featuring multiple biopharmaceutical companies1.
Comparison between gel (above left) and the CE electropherogram (above right), illustrates the increased resolution and quantification capability of CE SDS. The IgG Purity and Heterogeneity Assay allows you to analyze your denatured proteins in both a reduced and intact state as demonstrated in the illustration to the right.
Our replaceable CE SDS-gel consists of a proprietary polymer matrix that allows for:
Quantitative, high resolution, and automated separations of proteins from 10-225 kD
Sensitivity equivalent to silver-stained gels when using LIF detection2
High Resolution IgG Separation
The PA 800 plus IgG Purity and Heterogeneity Assay Kit (Part Number A10663) was designed in collaboration with biopharmaceutical analysts developing and manufacturing therapeutic MAb molecules. Assay methodology involves heat denaturation of IgG in the presence of SDS, followed by size separation using high-resolution capillary gel electrophoresis technology.
Detection of impurities below 0.1%
Repeatability of IgG mobility < 1% RSD
The IgG assay on the PA 800 plus features an internal system suitability control consisting of an IgG control standard with a designated quantity of non-glycosylated heavy chain to test both the resolution and quantitation suitability of the assay prior to running unknowns.
"A Series of Collaborations between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis." Chromatographia 2006, 64, September (No. 5/6).
Salas-Solano O., Tomlinson B., Du S., Parker M., Strahan A., Ma S. "Optimization and Validation of a Quantitative Capillary Electrophoresis Sodium Dodecyl Sulfate Method for Quality Control and Stability Monitoring of Monoclonal Antibodies." Analytical Chemistry 2006, 10.1021.
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