Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) is the only way to obtain automated, quantitative purity data (i.e. glycosylated vs non-glycosylated) on both intact and reduced monoclonal antibodies. It is quantitative, automated and fast.
CE-SDS data acquired by some technologies is regularly manipulated and enhanced. This may mask weaknesses in hardware and chemistries, and more importantly data quality. Only raw, unprocessed data can provide the confidence critical to both you and the regulatory for product submission and commercialization.
Only SCIEX CE technology uses circulating liquid temperature control to maximize data quality preventing the need for any data enhancement and manipulation. Additionally, our technology supports a wider range of method options.
SCIEX CE-SDS, the Gold Standard in Monoclonal Antibody (mAb) Purity Analysis
The Most Trusted Tools for the CE-SDS Environment
. Gel US Patent # US7,381,317. Automating the process of gel replacement is disclosed in US. . Patent # USRE37,606. . Chemistries referenced in USP Chapter <129>. . 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). . The PA 800 Plus ensures requirements of 21CFR211.194 can be met by providing raw, unmanipulated data. . US Patent 5,198,091. . USP Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies.
RUO-MKT18-7035-A For research use only. Not for use in diagnostic procedures.
The Best Technology Provides the Best Impurity Detection
In addition to quantitative data, automation, and full method development flexibility, the following benefits of SCIEX CE-SDS technology provide the critical confidence that you seek in your purity analysis from analytical development to QC.
Trusted Quantitative Data and Advanced Technology
The SCIEX CE-SDS proprietary replaceable gel technology, , is referenced in USP chapter <129>  and the application is recommended by a published intercompany collaboration.
Patented circulating liquid cooling of the capillary provides reproducible data that requires no enhancements nor manipulations. SCIEX CE-SDS always gives you secure raw data that better quantitates low MW species.
For ultimate sensitivity in impurity detection, upgrade to Laser Induced Fluorescence (LIF) detection. This upgrade (part # A59494) requires a PA 800 Plus or CESI 8000 Plus. This package consists of a durable solid-state laser and detector that can easily be switched with the PDA detection set-up.
The PA 800 Plus Pharmaceutical Analysis System is a robust analytical platform that provides characterization of product purity, charge heterogeneity and glycan analysis, to help you with the development and quality control of therapeutic proteins.