New Ion-Exchange Columns and Consumables Bring Flexibility, Reproducibility and Resolution to mAb Analysis
January 29 2019 - 10:00AM
Business Wire
New BioResolve SCX mAb Columns and Consumables
Simplify and Improve mAb Characterization and Monitoring through
Holistic Approach
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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version on businesswire.com: https://www.businesswire.com/news/home/20190129005602/en/
Brian MurphyWaters CorporationPublic
Relations508-482-2614brian_j_murphy@waters.com
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