MILFORD, Mass.--(BUSINESS WIRE)--Jan. 29, 2018--
Waters Corporation (NYSE:WAT) today introduced BioResolve™
RP mAb Polyphenyl 450 angstrom 2.7 micron solid core Columns
intended for the reversed-phase analysis of intact or sub-unit-digested
monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) using
LC-UV and LC-MS.
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Waters' new BioResolve RP mAb Polyphenyl Columns are for the analysis of intact or sub-unit-digested monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) by reversed phase liquid chromatography (LC) and LC-mass spectrometry. (Photo: Business Wire)
In addition to getting performance-driven columns, users of BioResolve
brand columns will receive application-focused standards, templated
methods, and an enhanced level of applications support to help ensure
that they can consistently and reliably perform state-of-the-art
bioseparations.
“A segment of the scientist community regards mAb and ADC separations as
overly complex. The causes of their frustrations are many and they
include poor data quality, degradation of the target mAbs, poor
recovery, excessive carryover and erratic results due to
column-to-column irreproducibility. To address these issues, we tasked
our research scientists to engineer a column that would raise the bar
for separation performance and take the hassle out of the measurement
process,” said Dr. Erin Chambers, Vice President, Chemistry, Waters
Corporation. ”Our ultimate goal is to enable biopharmaceutical
scientists to generate consistent results that meet international
regulatory requirements to confirm product efficacy and safety.”
Jacquelynn Smith, a member of Pfizer’s Analytical Research and
Development Department, St. Louis, Missouri who has evaluated the
BioResolve RP mAb Polyphenyl Column, said, “The newly introduced
BioResolve RP mAb Polyphenyl wider pore column provides superior
recovery, separation and resolution of therapeutic monoclonal antibody
(mAb) subunits and domains, as compared to other RP C4 columns on the
market. This resulted in higher quality product profiles for mAbs and
antibody drug conjugates, especially when hydrophobic subunits and
domains were encountered. The BioResolve RP mAb Polyphenyl column
addresses the key challenges of mAb and ADC subunit/domain analysis,
helps toward right-first time analyses, and will be a valuable addition
to our characterization toolbox.”
Her poster, High Resolution Chromatography – Mass Spectrometry with a
Novel Phenyl RPLC Column for Heightened Characterization of Hydrophobic
Monoclonal Antibodies and Antibody Drug Conjugates, will be
presented at the 22nd
Symposium on the Interface of Regulatory and Analytical Sciences for
Biotechnology Health Products (WCBP) in Washington, D.C., January 30
– February 1.
With the introduction of BioResolve RP mAb Polyphenyl Columns, Waters
continues its commitment to the biopharmaceutical industry by meeting
the needs of analytical scientists and lab managers across the
discovery, development and manufacturing pipeline.
Performance-Driven Particle and Bonding Technology
The combination of the BioResolve RP mAb Polyphenyl Column 450 angstrom
solid-core particle design and proprietary polyphenyl ligand bonding
makes it especially well-suited for reversed phase separations of intact
mAbs, IdeS generated fragments and similarly sized proteins. These
columns establish a new industry standard for separation selectivity,
efficiency, sample recovery and low injection-to-injection carryover
even when operated at lower temperatures.
The BioResolve RP mAb Polyphenyl 450 angstrom 2.7 micron Columns are
available in lengths of 50, 100 or 150 millimeters and internal
diameters of 2.1 or 4.6 millimeters for compatibility with UltraPerformance
Liquid Chromatography ™ (UPLC™), Ultra-High Performance
Liquid Chromatography (UHPLC) or High Performance Liquid Chromatography
(HPLC) separations platforms thus facilitating easy method transfer
between discovery, development and manufacturing/QC applications.
In addition, the columns are shipped with the same reduced IdeS-digested
NIST reference material that Waters uses to quality-test each batch of
stationary phase.
The new BioResolve RP mAb Polyphenyl Columns are now available worldwide
from Waters.
For more information: www.waters.com/bioresolve.
About Monoclonal Antibodies and Antibody Drug Conjugates
Monoclonal antibodies (mAbs) are the largest and fastest-growing segment
of the biotherapeutics market. They are a distinct type of bioengineered
molecule designed to sequester target proteins and/or modify cellular
pathways linked to a disease state. Like natural antibodies, they are
potent and highly selective for the targets they engage whether the
targets are outside cells or on the cells themselves. They can also
stimulate the immune system and mount a broader immune defense against a
disease like cancer. In one of the better known examples of their
therapeutic potential, former U.S. President Jimmy Carter’s stage-four
melanoma was sent into remission with Merck’s mAb, Keytruda.
Antibody drug conjugates (ADCs) are highly-potent, monoclonal antibodies
engineered to deliver a cytotoxic (anticancer) payload or drug to tumor
cells while sparing healthy cells. Their physico-chemical
characterization requires a large number of assays aimed at verifying
their molecular weight, sequence identity and post-translational
modifications.
The path to the commercialization of these and future drugs is paved
with information derived from LC and LC-MS analyses which are essential
for identifying critical quality attributes at all stages of the
discovery, development and manufacturing of mAbs.
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 nearly 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, UPLC and BioResolve are trademarks of Waters Corporation.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180129005797/en/
Source: Waters Corporation
Waters Corporation
Brian Murphy, 508-482-2614
Public Relations
Manager
brian_j_murphy@waters.com