Quantitative Protein Purity Analysis with SDS-Gel Capillary Electrophoresis
Monoclonal Antibodies (MAbs) make up a significant portion of therapeutic proteins, one of the fastest growing segments of global pharmaceutical development. A high level of assay sensitivity and resolution are critical to ensuring a quality product. The association of low-level impurities with these therapeutic proteins can mean the difference between the success and failure of a biologic.
The characterization of impurities down to 0.01% requires 3 orders of linear dynamic range of detection and quantitation. The PA 800 Plus capillary electrophoresis system provides this capability allowing you to generate consistent data with confidence.
High-Speed Separations When Time is of the Essence
A simple modification of the high resolution IgG assay is all it takes to increase the speed of CE separation without compromising assay sensitivity, or reproducibility, and all with minimal impact on resolution. This reduction in separation time is ideal for those occasions when you have large sample sets or are in a production environment and need to produce high-quality answers fast – as quickly as <12-18 min.
The PA 800 Plus delivers fast CE-SDS separation results with minimal impact on resolution while retaining excellent assay reproducibility for both reduced and non-reduced IgG analyses.
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.