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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.
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
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.
Waters, UPLC and BioResolve are trademarks of
Brian Murphy, 508-482-2614
Public Relations Manager