MILFORD, Mass., February 1, 2018 - Waters Corporation today introduced the BioResolve RP mAb Polyphenyl, 450 Å, 2.7 μm Solid Core for Complete Monoclonal Antibodies (mAb), mAb, LC-UV or LC-MS reverse-phase analysis of lysate and antibody conjugated drugs (ADCs).
Waters offers the new BioResolve RP mAb polybenzene column for target applications based on complete monoclonal antibodies (mAbs), mAbs, and antibody coupled drugs (ADCs) from reversed-phase liquid chromatography (LC) and LC- ) Analysis
BioResolve Series columns are performance-oriented in their design. In addition to the column itself, Waters offers standards, template methods, and higher-level application support services designed to meet the needs of different applications to ensure that users continue to deliver state-of-the- Isolate and get reliable results.
Erin Chambers, PhD, vice president of chemicals at Waters Corporation, said: 'Some scientists consider the separation of mAbs and ADCs too complex, and there are many reasons why they may be discouraging this type of analysis, such as poor data quality, target mAb degradation, Too much residue, poor column reproducibility results in erratic results, etc. To address these issues, Waters is devoted to designing a completely new column that will not only improve the separation performance but also eliminate The ultimate goal is to enable biopharmaceutical researchers to obtain results that meet the requirements of international regulations from start to finish to ensure product efficacy and safety. "
Jacquelynn Smith, research and development unit at Pfizer Inc. (St. Louis, MO), who participated in the evaluation of the BioResolve RP mAb polybenzene column, said: 'Compared to other RP C4 columns on the market, Waters' new BioResolve The RP mAb Polybenzo Big Macroporous Column exhibits excellent recovery and excellent separation performance when used to isolate therapeutic mAb subunits and functional domains. In addition, the resolution of the analytes is excellent. These advantages allow us to obtain better product profile data for mAb and antibody coupled drug assays, especially for the analysis of hydrophobic subunits and domains BioResolve RP mAb polybenzazole solves the problem of mAbs and ADCs subunits / One of our key characterization tools is the key challenge in ribbon analysis to help analyze the work in one go.
Jacquelynn Smith's Academic Poster 'Improving Characterization of Hydrophobic and Antibody-Coupled Drugs Using High-Resolution Chromatography-Mass Spectrometry Systems and New Phenyl-Based RPLC Columns', held in Washington, January 30 to February 1 The 22nd Biotech Health Products Regulatory and Analytical Science Communication Workshop (WCBP).
Waters has always been committed to meeting the diverse needs of biopharmaceutical analysts and laboratory managers in all stages of discovery, product development, and production lines, and the launch of the BioResolve RP mAb polybenzene column is Waters' Another proof of commitment.
Performance-oriented particles and bonding technology
The BioResolve RP mAb polybenzin column combines 450 Å solid core particle design with the patented polybenzene-bonded phase technique for reverse phase separation of intact mAb, IdeS digestion fragments and proteins of similar size. Selectivity, column efficiency, sample recovery, or residue between samples at low column temperatures, all set new industry standards for these columns.
BioResolve RP mAb Polynuclear, 450 Å, 2.7 μm columns are available in 50, 100 and 150 mm lengths and are available in 2.1 and 4.6 mm ID sizes compatible with UPLC, UHPLC or HPLC separations to assist researchers Easily accomplish method conversions in discovery research, product development, and production / QC applications.
In addition, the column is shipped with the same Waters Reagent-degraded NIST reference material for quality testing of each batch of stationary phase.
Waters is now shipping the new BioResolve RP mAb polybenzene column worldwide.
For more information, visit www.waters.com/bioresolve.
About Monoclonal Antibodies and Antibody Coupling Drugs
Monoclonal antibodies (mAbs) are the largest and fastest growing class of drugs in the market for biotherapeutics, a unique class of carefully engineered, unique bioengineered molecules that bind to and / or modify the proteins of interest in disease states Related to Cell Pathways. Like natural antibodies, mAb targets and exerts great potency to target cells both extracellularly and intracellularly. In addition, it stimulates the immune system to create a broader range of diseases such as cancer Immune Defense. The best known example of the therapeutic potential of mAb is the key mAb mAb Keytruda developed by Merck, which eased the terminal melanoma in former U.S. President Jimmy Carter.
Antibody-conjugated drugs (ADCs) are potent monoclonal antibodies that are bioengineered to deliver cytotoxic (anti-cancer) payloads or drugs to tumor cells without affecting healthy cells. To characterize their physicochemical properties, You must determine the molecular weight, sequence, and posttranslational modifications of such materials through extensive analysis.
The commercialization of these drugs and future drugs needs to be based on LC and LC-MS data, and LC and LC-MS analyzes are important tools for determining key quality attributes at all stages of mAb discovery research, product development and production.