New BioResolve SCX mAb Columns and Consumables Simplify and Improve
mAb Characterization and Monitoring through Holistic Approach
MILFORD, Mass.--(BUSINESS WIRE)--Jan. 29, 2019--
Waters Corporation (NYSE:WAT) today 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.
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The new Waters BioResolve SCX mAb Columns with Vanguard™ FIT Cartridge technology, together with a suite of complementary consumables, simplify and improve the characterization and monitoring of monoclonal antibody (mAb) therapeutics. (Photo: Business Wire)
“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.”
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.
The columns are also available with a first–of-its-kind Vanguard Fully
Integrated Technology (FIT) Cartridge which prevents particulates and
other contaminants from being carried onto the column thereby extending
its working life and reducing the cost-per-analysis without compromising
the quality of the separation. Each batch of material for the BioResolve
SCX mAb columns and VanGuard FIT cartridges are specifically quality
control-tested with a new and commercially-available mAb charge variant
standard derived from the National Institute of Science and Technology
Reference Material 8671 (i.e. humanized IgG1κ) to help ensure
batch-to-batch consistency of the new offering.
When used with Waters liquid chromatography systems equipped with Auto•Blend™
PLUS technology, scientists can take advantage of pre-configured Empower™
software methods and automatically blend up to four solvents in any
combination or proportion and program in pH and ionic strength. This
significantly reduces human error and eliminates the task of preparing
buffered mobile phases manually. Waters has also specifically formulated
new BioResolve SCX pH buffer concentrates with recommended gradient
separation conditions for those scientists looking for a “turnkey”
solution for mAb charge variant analyses.
The introduction of the new BioResolve SCX mAb Columns and consumables,
along with the recent introduction of the Waters BioAccord™ System,
reinforce Waters commitment to innovation and to addressing the evolving
needs of the biopharmaceutical industry.
Waters BioResolve SCX mAb Columns and consumables are now available
worldwide.
For more information on the Waters BioResolve SCX mAb Consumables and
Vanguard FIT Cartridges, go to: www.waters.com/bioresolve.
About Waters Corporation (www.waters.com)
Waters Corporation (NYSE:WAT), the world's leading specialty measurement
company, has pioneered chromatography, mass spectrometry, and thermal
analysis innovations serving the life, materials, and food sciences for
more than 60 years. With approximately 7,000 employees worldwide, Waters
operates directly in 31 countries, including 15 manufacturing
facilities, and with products available in more than 100 countries.
Waters, Empower, ACQUITY, Auto•Blend, UPLC, BioResolve and Vanguard are
trademarks of Waters Corporation.
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Source: Waters Corporation
Brian Murphy
Waters Corporation
Public Relations
508-482-2614
brian_j_murphy@waters.com