For Use with Waters UPLC Technology, Improves Protein Charge Variant Monitoring of Biotherapeutics

Waters Corporation (WAT:NYSE) introduced at Pittcon 2010 its new Protein-Pak^TM Hi Res, Ion-Exchange (IEX) columns designed for use with Waters ACQUITY® UltraPerformance LC® (UPLC) System for the analysis of biomolecules including monoclonal antibodies, recombinant proteins, DNA/RNA, and vaccine components. These columns give biopharmaceutical manufacturers the ability to reproducibly characterize, with greater resolution and speed, various charge states of intact biomolecules. This improved monitoring capability helps manufacturers ensure high product quality and efficacy.

Waters® Protein-Pak Hi Res IEX family of columns were developed to assist in the UPLC® characterization of recombinant proteins and monoclonal antibodies found in many of today's novel biopharmaceutical therapeutics. These non-porous, high-ligand density particles overcome the effects of protein diffusion on peak volume and resolution experienced when using traditional porous IEX particles for large molecule separations. In addition, the novel particle and surface chemistry delivers high sample loading capacities and component resolution while minimizing column fouling.

The available ion-exchange chemistries include a strong anion-exchange (quaternary ammonium, Q) and a weak strong-cation exchanger (carboxy methyl [CM] and sulfopropyl [S]), all of which are stable over a wide pH range (3-10), high salt concentrations and operating pressures via use of polymer-based particles.

Ion-exchange chromatography is a proven and important technique for assessing the charge states of biomolecules. Biomolecules are notoriously difficult to reproducibly manufacture and protein charge variances are good indicators of deamidation or glycosylation that may affect product stability and efficacy and are thus closely monitored. The columns are available immediately from Waters Corporation. For more information, go to (www.waters.com/proteins).

Expanding the Capabilities of UPLC Technology to Biomolecules

In 2004, Waters introduced its ACQUITY UPLC system that revolutionized the quality of LC separations while significantly increasing sample throughput compared to the use of traditional HPLC technology. Waters' new Protein-Pak Hi Res IEX columns are ideally suited for use on Waters ACQUITY UPLC System that is optimized to maximize sensitivity while maintaining chromatographically important component resolution. In addition, each column features Waters ACQUITY UPLC eCord^TM Technology that helps monitor critical individual column use parameters throughout the lifetime of the column - information that always accompanies the column.

Together, these combined technologies dramatically enhance the characterization of monoclonal antibodies, recombinant proteins, DNA or RNA, and vaccine components.

About Waters Corporation (www.waters.com)

Waters Corporation (NYSE:WAT) creates business advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide.

Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters' technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.5 billion in 2009 and 5,200 employees, Waters is driving scientific discovery and operational excellence for customers worldwide.