Waters Introduces First UPLC SEC Solution to Enable Biopharmaceutical Manufacturers to Meet New Quality Control Regulations

Waters Corporation introduces the first UltraPerformance LC® (UPLC®) analytical size-exclusion chromatography (SEC) solution for the characterization of proteins and their aggregates. The UPLC solution combines the first commercial sub two micron particle for SEC applications – the new patent–pending ACQUITY® UPLC BEH200, 1.7µm SEC Columns - with the Waters® ACQUITY UPLC System to give manufacturers the ability to separate and quantify monoclonal antibodies (mAb) and their aggregates in less than four minutes, faster than with conventional liquid chromatography, and still meet FDA requirements.

Waters is introducing this analytical solution at the request of scientists seeking to apply the power of UPLC technology to the SEC analysis of proteins such as therapeutic mAbs.

“Since the launch of ACQUITY, our biopharmaceutical customers have asked us to bring the benefits of UPLC performance to size-exclusion chromatography,” said Dr. Dorothy Phillips, Director of Chemistry Operations Strategic Marketing, Waters Division. “Overcoming this incredible challenge was only possible after much innovation and invention. Our new solution allows customers to monitor monoclonal antibody aggregation at speeds up to 10 times faster at comparable or better resolution than before, helping them overcome their challenges of developing novel biotherapeutics in less time and at lower costs.”

Waters ACQUITY UPLC BEH SEC columns are specially QC tested with protein mixtures to ensure batch to batch reproducibility. In addition, each column features Waters ACQUITY UPLC eCord™ Technology that helps monitor critical individual column use parameters throughout the lifetime of the column – information that always accompanies the column.

Size exclusion chromatography is a proven technique that separates large molecules, including proteins and protein aggregates, on the basis of their size in solution. Waters new ACQUITY UPLC SEC solution makes it faster and easier for manufacturers to achieve high-confident data that meets FDA requirements for quantifying protein aggregates suspected of being capable of producing an immunogenic response in certain patients.