31 January 2019 | News
New BioResolve SCX mAb columns and consumables simplify and improve mAb characterization and monitoring through holistic approach.
Waters Corporation has introduced a new cation exchange column line with specialized consumables to simplify and improve the characterization and monitoring of monoclonal antibody (mAb) therapeutics.
The new BioResolve™ SCX mAb Columns and Vanguard™ FIT Cartridge technologies, together with a suite of complementary consumables, enable mAb charge-variant analyses as required by the World Health Organization, the U.S. Food and Drug Administration, and the International Conference on Harmonization for confirming the efficacy and safety of biologics and biosimilars within discovery, development, and manufacturing applications.
BioResolve SCX mAb Columns contain an innovative strong-cation exchanger based on a novel polymeric composition, hydrophilic coating and multi-component surface chemistry all synthesized at Waters chemistry manufacturing facility. The base material consists of three-micron non-porous particles for optimal diffusion kinetics, high pressure capability and compatibility with HPLC, UHPLC and UPLC™ methods.
“With the introduction of these product offerings, we’re taking a holistic approach to mAb analysis and moving it a significant step forward. Scientists now have a complete set of tools for mAb charge variant analyses that will give them a more complete and detailed picture of their mAbs and the relationship between mAb structure and their function,” said Dr. Erin Chambers, Vice President, Chemistry, Waters Corporation. “Our goal is to help streamline analytical workflows and speed up drug candidate development to get needed therapeutics to patients faster.”