Developing new life-saving drugs and improving the efficacy and quality of existing therapeutic biologics drive the demand for innovation in the biopharmaceutical industry. To address this need, AB SCIEX LLC, a global leader in analytical technologies, today introduced a breakthrough technology solution called CESI-MS. CESI marks a novel combination of capillary electrophoresis (CE) and electrospray ionization (ESI) technologies to create an integrated workflow solution unlike anything else on the market. With this new solution, biopharmaceutical scientists will be able to more accurately predict efficacy, reduce the time to market for new therapeutics and proactively detect potential issues before they lead to costly product recalls.
The CESI-MS workflow includes the industry's first commercially available ultra low-flow separation and ESI module for biologics, along with a high-performance, high-resolution, accurate mass instrument that is ideal for biopharmaceutical development. The new CESI 8000 System for Biologics Characterization is an innovative, high-performance separation-electrospray ionization system for mass spectrometry (MS). This new front-end CESI technology from the company's SCIEX Separations business can be integrated with the well-established AB SCIEX TripleTOF® 5600+ mass spectrometry system into a seamless solution, for example, to give biopharmaceutical scientists the ability to advance therapeutics discovery, research and development through the life cycle of the product.
Increase efficiency and productivity
With a single approach that increases efficiency and productivity, the CESI 8000 system provides orthogonal and/or superior results compared to dual-method liquid chromatography / mass spectrometry-based approaches. From a single digest and run, users of CESI-MS gain the following: (a) Identity and Purity information with 100 percent coverage in a peptide map; (b) Heterogeneity information with ultrasensitive glycopeptide quantitation; and (c) Stability information identifying, deamidation, cyclization and oxidation ‒ all highly important to biopharmaceutical scientists.
"AB SCIEX is partnering with biopharmaceutical companies around the world to advance biologics," said Jeff Chapman, Director of the CE Business within SCIEX Separations, a part of AB SCIEX. "With CESI-MS, we are establishing a new benchmark of improved system performance for routine biologics analysis in a way that allows CESI to be easily integrated into existing workflows in biopharmaceutical laboratories. This is innovation delivered to help save more lives and address the unmet needs of our customers in biopharma."
The CESI 8000 system is the first CE-related product launch from AB SCIEX. Expanding its portfolio of separations solutions, AB SCIEX obtained the CESI technology through combining the CE business of Beckman Coulter Life Sciences with Eksigent nano and microscale chromatography to form a newly expanded separations business known as SCIEX Separations.
AB SCIEX's BiologicsFocus Initiative
The new CESI-MS solution is part of AB SCIEX's BiologicsFocus Initiative, which is a long-term strategy for AB SCIEX to meet the evolving needs of biopharmaceutical scientists by providing innovative technologies and workflow solutions for therapeutic biologics.
"The new CESI system complements our AB SCIEX 'quantitation by design' approach, which puts the power of highly accurate quantitative analysis of large molecules into the hands of biopharma scientists," said Joe Fox, Senior Director of the Pharmaceutical Business at AB SCIEX. "As we work with biopharma companies on addressing new challenges, we see a rising demand for mass spectrometry in biologics that we are uniquely positioned to address. Our history and experience in this area, which now dates back more than a decade, combined with the exciting addition of the CESI product to the portfolio, will allow us to further our support of these key customers."
CE technology is already well integrated into the workflows of biopharmaceutical companies for the characterization and quality control of therapeutic antibodies, providing fast and efficient separations of intact biologics, automating SDS-Gel, isoelectric focusing and glycan analysis. The technical benefit of the CESI innovation delivered to biopharmaceutical laboratories is an improvement in biophysicochemical characterization to guide the development of biologics-based therapeutics. Specifically, CESI-MS serves to improve ionization efficiency and reduce ion suppression. AB SCIEX is delivering this advancement as a robust solution - without requiring specialized expertise in CE or MS.
The CESI 8000, which is manufactured by Beckman Coulter, is an expansion to the CE portfolio within the newly expanded SCIEX Separations. This portfolio also includes the PA 800 plus™pharmaceutical analysis system, the GeXP™ genetic analyzer and the P/ACE™ MDQ capillary electrophoresis system.
Switching between LC-MS and CESI-MS has also been made simple, which will help facilitate adoption of CESI-MS technology. The data that are generated on the CESI-based workflow are complementary to data from LC-MS/MS solutions.