Dionex - Monoclonal Antibody Characterization

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Monoclonal Antibody Characterization

Thermo scientific is a leader in monoclonal antibody analysis, providing state-of-the-art HPLC systems, software, and innovative column chemistries. We provide the means to achieve the highest-quality analysis and highest throughput for monoclonal antibody samples.

Automated multi-step workflow (PDF, 1.9 Mb)
High-throughput analysis
Highest-resolution analytical separations

The development of monoclonal antibody therapeutics is one of the largest and most important areas in biomedical research today. Analytical characterization of antibodies is required during various stages in the development of biopharmaceuticals. Monoclonal antibody samples are typically screened for titer, aggregation, and heterogeneity, including charge variant analysis.

MAb analysis solutions meet the quality analysis and high-throughput requirements of monoclonal antibody therapeutic development projects. Our solutions consists of the Thermo Scientific Dionex UltiMate 3000 biocompatible HPLC systems, Thermo Scientific Dionex Chromeleon software, and innovative column chemistries that address every facet of the chromatographic analysis of monoclonal antibodies.

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Bio Columns for Monoclonal Antibody Characterization

MAbPac^™ SCX-10: High-resolution ion-exchange column designed for monoclonal antibody charge variant analysis
Thermo Scientific ProPac WCX-10: High-resolution ion-exchange column for charge variant analysis
MAbPac SEC-1: Size-exclusion column for aggregate analysis
ProPac ^™ HIC: Hydrophobic-interaction chromatography analysis

MAb Analysis Platforms

UltiMate 3000 Biocompatible Analytical LC system
x2 Dual LC system for high throughput and multistep automation
Analytical Autosampler with Fraction Collector
UltiMate 3000 RSLCnano Rapid Separation Nano Liquid Chromatography system
UltiMate 3000 Proteomics MDLC system

Dionex Chromatography Data System

Chromeleon 7 Chromatography Data System software

Brochures
	Monoclonal Antibody Characterization

Charge Variants Analysis by IEX Methods
	AN 127: Analysis of Monoclonal Antibody Heterogeneity by Cation-Exchange Chromatography: Separation of C-Terminal Lysine Variants
	AN 128: Monitoring Stability of Monoclonal Antibodies by Cation-Exchange Chromatography
	AN 125: Monitoring Protein Deamidation by Cation-Exchange Chromatography
	AN 126: Determination of Hemoglobin Variants by Cation-Exchange Chromatography
	AN 214: Separation of Protein Phosphoisoforms Using Strong Anion-Exchange Chromatography
	AN 129: Separation of Tryptophan and Methionine Oxidized Peptides from Their Unoxidized Forms
	AB 101: High-Resolution Cation-Exchange Chromatography for Analysis of Protein Purity and Microheterogeneity
	CAN: 110 Rapid Analysis of Recombinant Protein Production During Fermentation Using Dionex ProPac SCX Columns

Variants Analysis by HIC Methods
	AN 211: Hydrophobic Interaction Chromatography for Separation of Tryptophan and Methionine Oxidized Peptides from Their Native Forms
	High Resolution Silica Hydrophobic Interaction Chromatography (HIC) Column for Protein/Peptide Separations with Improved Hydrolytic Stability

Antibody and His-Tag Protein Separations by IMAC Methods
	CAN 107: Rapid His-Tag Purification of Recombinant Proteins Using Dionex ProPac IMAC Columns
	AN 177: Separation of an Intact Monoclonal Antibody and Fractionation of Monoclonal Antibody Papain Digest Fragments Using Immobilized Metal Affinity Chromatography (IMAC)
	Article: Separation of His-tag Protein Aggregation Variants on the New Analytical ProPac IMAC-10 Column
	High Resolution Protein and Peptide Separations on a Nanoengineered Analytical IMAC Column

Purity Analysis by RP Methods
	AN 230: Purity Analysis of Synthetic Thymosin Alpha 1 by Reversed-Phase HPLC with an Acclaim 300 C18 Column

Peptide Mapping
	AN 99: Peptide Mapping of Ovalbumin Using Reversed-Phase High-Performance Liquid Chromatography and Prediction of Phosphopeptide Elution
	UHPLC-MS/MS to Monitor Modifications in Biopharmaceuticals

High Throughput and Automated Methods for Antibody Screening
	Development of an Automated Method for Monoclonal Antibody Purification and Analysis
	Should Your Autosampler Just Sit and Wait? Intelligent Instrument Control Allows Sharing HPLC Modules Across Systems

Benefits of Biocompatible HPLC for Biomolecules Separation
	Analysis of Monoclonal Antibody Charge Heterogeneity Using Ion-Exchange Chromatography on a Fully Biocompatible HPLC System
	Optimal Method Development for Separation of Monoclonal Antibodies Using ProPac Weak Cation-Exchange (ProPac WCX) Columns: Effect of Iron on Column Performance

Biopharmaceutical Glycan Analysis Using High-Performance Anion-Exchange Chromatography (HPAE-PAD)
	AN 215: Separation of Asparagine-Linked (N-Linked) Oligosaccharides from Human Polyclonal IgG Using the CarboPac PA200 Column
	AN 105: Glycosylation Analysis of Human Serum Transferrin Glycoforms Using Pellicular Anion-Exchange Chromatography
	AU 181: Rapid Screening of Sialic Acids in Glycoproteins by HPAE-PAD
	AU 180: Direct Determination of Sialic Acids in Glycoprotein Hydrolyzates by HPAE-PAD
	TN 53: Determination of Glycoprotein Monosaccharide Composition by HPAE-PAD Using On-Line Electrolytically Generated Eluents
	TN 42: Glycoprotein Oligosaccharide Analysis Using High-Performance Anion-Exchange Chromatography
	TN 36: Analysis of Exoglycosidase Digestions of N-Linked Oligosaccharides Using HPAE-PAD
	TN 20: Analysis of Carbohydrates by High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAE-PAD)

Posters
	Intelligent Design of the Ion-Exchange Analytical Column for Monoclonal Antibody Chracterization
	Strategies for Coupling of Nonvolatile Salt-Based HPLC to MS Detection for the Separation and Characterization of Related Substances in Biopharmaceuticals
	Impact of Polymeric Ion-Exchange Columns’ Designs on the Separation of Proteins
	Exploration of pH-Gradient Ion-Exchange Chromatography for High-Resolution Protein Separations in Biotechnology and Proteomics
	AU 183: Separation of Peptides from Enzymatic Digestion on Different Acclaim Columns: A Comparative Study

Selected Peer Reviewed Publications
Analysis of Recombinant Monoclonal Antibody Isoforms by Electrospray Ionization Mass Spectrometry as a Strategy for Streamlining Characterization of Recombinant Monoclonal Antibody Charge Heterogeneity. Lyubarskaya, Y.; Houde, D.; Woodard, J.; Murphy, D.; Mhatre, R. Anal. Biochem. 2006, 348, 24–39.
Heterogeneity of Monoclonal Antibodies Revealed by Charge-Sensitive Methods. Vlasak, J; Ionescu, R. Curr. Pharm. Biotechnol. 2008, 9, 468-481.
Separation of Populations of Antibody Variants by Fine Tuning of Hydrophobic-Interaction Chromatography Operating Conditions. Valliere-Douglass, J.; Wallace, A.; Balland, A. J. Chromatogr., A 2008, 1214, 81–89.
Development of an Automated Method for Monoclonal Antibodies Purification and Analysis. Decrop, W.; Gendeh, G.; Swart, R. Chromatography Today, May/June 2009
Multiproduct High-Resolution Monoclonal Antibody Charge Variant Separations by pH Gradient Ion-Exchange Chromatography. Farnan, D.; Moreno, G. T. Anal. Chem. 2009, 81 (21), 8846 –57.
Interlaced Size-Exclusion Liquid Chromatography of Monoclonal Antibodies. Farnan, D.; Moreno, G. T.; Stults, J.; Becker, A.; Tremintin, G.; van Gils, M. J Chromatogr., A 2009, 1216 (51), 8904 –9.
Reversible Interference of Fe³⁺ With Monoclonal Antibody Analysis in Cation-Exchange Columns. Rao, S.; Pohl, C. Anal. Biochem. 2011, 409 (2), 293 –5.

Application Notebooks
- Protein Therapeutics Applications Notebook
- Nucleic Acid Applications Notebook

News
- Dionex Introduces the UltiMate 3000 Titanium LC System for Biomolecule Analysis

Columns
- Bio Columns
- Reversed-Phase LC Columns

MAb Analysis Column Kits
- MAb Charge Variants Analysis IEX Column Kit
- MAb Analysis IEX and SEC Column Kit

Ion Chromatography
- Carbohydrate Analysis

Chromatography Data Systems
- Chromeleon 7.1 Chromatography Data System
- Chromeleon 6.8 Chromatography Data System