Use CE-SDS for Proven, Consistent Purity/Heterogeneity Data
Variations in low-level impurities with therapeutic proteins is a common challenge throughout the biopharma pipeline – it can adversely impact efficacy and safety.
Biopharma analytical labs require quantitative, validated, automated and streamlined techniques that deliver consistent data. They must also be able to keep pace with workloads while also keeping sample prep and processing time to a minimum. Not to mention adhering to regulatory preferences.
Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) satisfies these demands and provides automated, quantitative purity data (i.e. glycosylated vs non-glycosylated) on both intact and reduced monoclonal antibodies. It is quantitative, automated and fast.
With SCIEX CE-SDS solutions you can also have absolute confidence in your data from best-in-class systems trusted by virtually all manufacturers of commercial therapeutic monoclonal antibodies. Make the right decisions based on consistent quantitation resulting from extremely sensitive technology with the only CE-SDS technology that provides reproducible raw data required for regulatory approval. This is achieved through circulating liquid cooling and thermostating for tight temperature control, leading to consistent migration time and peak area reproducibility.
SCIEX innovative CE-SDS solutions cut through the challenges of purity/heterogeneity characterization, giving you the upmost confidence in your data by using leading edge methods that will improve the performance, productivity and compliance of your lab.
The PA 800 Plus Pharmaceutical Analysis System coupled with CE-SDS Assays, help you with the development and quality control of therapeutic proteins. The PA 800 Plus is a robust analytical platform that provides characterization of product purity, charge heterogeneity and glycan analysis. The CE SDS-gel application has become the gold standard for protein purity analysis in biopharmaceutical laboratories, replacing manual, low resolution SDS-PAGE. Denatured proteins can be reduced or left intact for separation and subsequent analysis.
1. “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). 2. See US Patent # US7,381,317. Automating the process of gel replacement is disclosed in US Patent # USRE37,606