Protein Analysis using Mass Spectrometry (eBook, ePUB)
Accelerating Protein Biotherapeutics from Lab to Patient
Redaktion: Lee, Mike S.; Ji, Qin C.
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Protein Analysis using Mass Spectrometry (eBook, ePUB)
Accelerating Protein Biotherapeutics from Lab to Patient
Redaktion: Lee, Mike S.; Ji, Qin C.
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Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development * Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery * Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis * Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer,…mehr
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- Produktdetails
- Verlag: John Wiley & Sons
- Seitenzahl: 288
- Erscheinungstermin: 30. Mai 2017
- Englisch
- ISBN-13: 9781119359357
- Artikelnr.: 52558349
- Verlag: John Wiley & Sons
- Seitenzahl: 288
- Erscheinungstermin: 30. Mai 2017
- Englisch
- ISBN-13: 9781119359357
- Artikelnr.: 52558349
Analysis by Ion Mobility Mass Spectrometry 1 Johannes P.C. Vissers and
James I. Langridge 1.1 Introduction 1 1.2 Traveling-Wave Ion Mobility Mass
Spectrometry 1 1.3 IM-MS and LC-IM-MS Analysis of Simple and Complex
Mixtures 2 1.4 Outlook 7 Acknowledgment 8 References 8 2 High-Resolution
Accurate Mass Orbitrap and Its Application in Protein Therapeutics
Bioanalysis 11 Hongxia Wang and Patrick Bennett 2.1 Introduction 11 2.2
Triple Quadrupole Mass Spectrometer and Its Challenges 11 2.3
High-Resolution Mass Spectrometers 12 2.4 Quantitation Modes on Q Exactive
Hybrid Quadrupole Orbitrap 13 2.5 Protein Quantitation Approaches Using Q
Exactive Hybrid Quadrupole Orbitrap 14 2.6 Data Processing 16 2.7 Other
Factors That Impact LC-MS-based Quantitation 16 2.8 Conclusion and
Perspectives of LC-HRMS in Regulated Bioanalysis 18 References 18 3 Current
Methods for the Characterization of Posttranslational Modifications in
Therapeutic Proteins Using Orbitrap Mass Spectrometry 21 Zhiqi Hao, Qiuting
Hong, Fan Zhang, Shiaw-Lin Wu, and Patrick Bennett 3.1 Introduction 21 3.2
Characterization of PTMs Using Higher-Energy Collision Dissociation 23 3.3
Application of Electron Transfer Dissociation to the Characterization of
Labile PTMs 26 3.4 Conclusion 31 Acknowledgment 32 References 32 4 Macro-
to Micromolecular Quantitation of Proteins and Peptides by Mass
Spectrometry 35 Suma Ramagiri, Brigitte Simons, and Laura Baker 4.1
Introduction 35 4.2 Key Challenges of Peptide Bioanalysis 36 4.3 Key
Features of LC/MS/MS-Based Peptide Quantitation 38 4.4 Advantages of the
Diversity of Mass Spectrometry Systems 41 4.5 Perspectives for the Future
41 References 42 5 Peptide and Protein Bioanalysis Using Integrated
Column-to-Source Technology for High-Flow Nanospray 45 Shane R. Needham and
Gary A. Valaskovic 5.1 Introduction - LC-MS Has Enabled the Field of
Protein Biomarker Discovery 45 5.2 Integration of Miniaturized LC with
Nanospray ESI-MS Is a Key for Success 46 5.3 Micro- and Nano-LC Are Well
Suited for Quantitative Bioanalysis 47 5.4 Demonstrating Packed-Emitter
Columns Are Suitable for Bioanalysis 49 5.5 Future Outlook 51 References 52
6 Targeting the Right Protein Isoform: Mass Spectrometry-Based Proteomic
Characterization of Alternative Splice Variants 55 Jiang Wu 6.1
Introduction 55 6.2 Alternative Splicing and Human Diseases 55 6.3
Identification of Splice Variant Proteins 56 6.4 Conclusion 64 References
64 7 The Application of Immunoaffinity-Based Mass Spectrometry to
Characterize Protein Biomarkers and Biotherapeutics 67 Bradley L. Ackermann
and Michael J. Berna 7.1 Introduction 67 7.2 Overview of IA-MS Methods 69
7.3 IA-MS Applications - Biomarkers 74 7.3.1 Peptide Biomarkers 74 7.4
IA-MS Applications - Biotherapeutics 81 7.5 Future Direction 84 References
85 8 Semiquantification and Isotyping of Antidrug Antibodies by
Immunocapture-LC/MS for Immunogenicity Assessment 91 Jianing Zeng, Hao
Jiang, and Linlin Luo 8.1 Introduction 91 8.2 Multiplexing Direct
Measurement of ADAs by Immunocapture-LC/MS for Immunogenicity Screening,
Titering, and Isotyping 93 8.3 Indirect Measurement of ADAs by Quantifying
ADA Binding Components 95 8.4 Use of LC-MS to Assist in Method Development
of Cell-Based Neutralizing Antibody Assays 96 8.5 Conclusion and Future
Perspectives 97 References 97 9 Mass Spectrometry-Based Assay for
High-Throughput and High-Sensitivity Biomarker Verification 99 Xuejiang Guo
and Keqi Tang 9.1 Background 99 9.2 Sample Processing Strategies 100 9.3
Advanced Electrospray Ionization Mass Spectrometry Instrumentation 102 9.4
Conclusion 105 References 105 10 Monitoring Quality of Critical Reagents
Used in Ligand Binding Assays with Liquid Chromatography Mass Spectrometry
(LC-MS) 107 Brian Geist, Adrienne Clements-Egan, and Tong-Yuan Yang 10.1
Introduction 107 10.2 Case Study Examples 114 10.3 Discussion 122
Acknowledgment 126 References 126 11 Application of Liquid
Chromatography-High Resolution Mass Spectrometry in the Quantification of
Intact Proteins in Biological Fluids 129 Stanley (Weihua) Zhang, Jonathan
Crowther, and Wenying Jian 11.1 Introduction 129 11.2 Workflows for
Quantification of Proteins Using Full-Scan LC-HRMS 131 11.3 Internal
Standard Strategy 133 11.4 Calibration and Quality Control (QC) Sample
Strategy 135 11.5 Common Issues in Quantification of Proteins Using LC-HRMS
135 11.6 Examples of LC-HRMS-Based Intact Protein Quantification 137 11.7
Conclusion and Future Perspectives 138 Acknowledgment 140 References 140 12
LC-MS/MS Bioanalytical Method Development Strategy for Therapeutic
Monoclonal Antibodies in Preclinical Studies 145 Hongyan Li, Timothy Heath,
and Christopher A. James 12.1 Introduction: LC-MS/MS Bioanalysis of
Therapeutic Monoclonal Antibodies 145 12.2 Highlights of Recent Method
Development Strategies 146 12.3 Case Studies of Preclinical Applications of
LC-MS/MS for Monoclonal Antibody Bioanalysis 154 12.4 Conclusion and Future
Perspectives 156 References 158 13 Generic Peptide Strategies for LC-MS/MS
Bioanalysis of Human Monoclonal Antibody Drugs and Drug Candidates 161
Michael T. Furlong 13.1 Introduction 161 13.2 A Universal Peptide LC-MS/MS
Assay for Bioanalysis of a Diversity of Human Monoclonal Antibodies and Fc
Fusion Proteins in Animal Studies 161 13.3 An Improved "Dual" Universal
Peptide LC-MS/MS Assay for Bioanalysis of Human mAb Drug Candidates in
Animal Studies 165 13.4 Extending the Universal Peptide Assay Concept to
Human mAb Bioanalysis in Human Studies 170 13.5 Internal Standard Options
for Generic Peptide LC-MS/MS Assays 173 13.6 Sample Preparation Strategies
for Generic Peptide LC-MS/MS Assays 175 13.7 Limitations of Generic Peptide
LC-MS/MS Assays 177 13.8 Conclusion 178 Acknowledgments 178 References 178
14 Mass Spectrometry-Based Methodologies for Pharmacokinetic
Characterization of Antibody Drug Conjugate Candidates During Drug
Development 183 Yongjun Xue, Priya Sriraman, Matthew V. Myers, Xiaomin
Wang, Jian Chen, Brian Melo, Martha Vallejo, Stephen E. Maxwell, and Sekhar
Surapaneni 14.1 Introduction 183 14.2 Mechanism of Action 183 14.3 Mass
Spectrometry Measurement for DAR Distribution of Circulating ADCs 186 14.4
Total Antibody Quantitation by Ligand Binding or LC-MS/MS 189 14.5 Total
Conjugated Drug Quantitation by Ligand Binding or LC-MS/MS 193 14.6
Catabolite Quantitation by LC-MS/MS 196 14.7 Preclinical and Clinical
Pharmacokinetic Support 197 14.8 Conclusion and Future Perspectives 198
References 198 15 Sample Preparation Strategies for LC-MS Bioanalysis of
Proteins 203 Long Yuan and Qin C. Ji 15.1 Introduction 203 15.2 Sample
Preparation Strategies to Improve Assay Sensitivity 205 15.3 Sample
Preparation Strategies to Differentiate Free, Total, and ADA-Bound Proteins
213 15.4 Sample Preparation Strategies to Overcome Interference from
Antidrug Antibodies or Soluble Target 214 15.5 Protein Digestion Strategies
214 15.6. Conclusion 215 Acknowledgment 216 References 216 16
Characterization of Protein Therapeutics by Mass Spectrometry 221 Wei Wu,
Hangtian Song, Thomas Slaney, Richard Ludwig, Li Tao, and Tapan Das 16.1
Introduction 221 16.2 Variants Associated with Cysteine/Disulfide Bonds in
Protein Therapeutics 221 16.3 N-C-Terminal Variants 225 16.4 Glycation 226
16.5 Oxidation 226 16.6 Discoloration 228 16.7 Sequence Variants 230 16.8
Glycosylation 232 16.9 Conclusion 240 References 240 Index 251
Analysis by Ion Mobility Mass Spectrometry 1 Johannes P.C. Vissers and
James I. Langridge 1.1 Introduction 1 1.2 Traveling-Wave Ion Mobility Mass
Spectrometry 1 1.3 IM-MS and LC-IM-MS Analysis of Simple and Complex
Mixtures 2 1.4 Outlook 7 Acknowledgment 8 References 8 2 High-Resolution
Accurate Mass Orbitrap and Its Application in Protein Therapeutics
Bioanalysis 11 Hongxia Wang and Patrick Bennett 2.1 Introduction 11 2.2
Triple Quadrupole Mass Spectrometer and Its Challenges 11 2.3
High-Resolution Mass Spectrometers 12 2.4 Quantitation Modes on Q Exactive
Hybrid Quadrupole Orbitrap 13 2.5 Protein Quantitation Approaches Using Q
Exactive Hybrid Quadrupole Orbitrap 14 2.6 Data Processing 16 2.7 Other
Factors That Impact LC-MS-based Quantitation 16 2.8 Conclusion and
Perspectives of LC-HRMS in Regulated Bioanalysis 18 References 18 3 Current
Methods for the Characterization of Posttranslational Modifications in
Therapeutic Proteins Using Orbitrap Mass Spectrometry 21 Zhiqi Hao, Qiuting
Hong, Fan Zhang, Shiaw-Lin Wu, and Patrick Bennett 3.1 Introduction 21 3.2
Characterization of PTMs Using Higher-Energy Collision Dissociation 23 3.3
Application of Electron Transfer Dissociation to the Characterization of
Labile PTMs 26 3.4 Conclusion 31 Acknowledgment 32 References 32 4 Macro-
to Micromolecular Quantitation of Proteins and Peptides by Mass
Spectrometry 35 Suma Ramagiri, Brigitte Simons, and Laura Baker 4.1
Introduction 35 4.2 Key Challenges of Peptide Bioanalysis 36 4.3 Key
Features of LC/MS/MS-Based Peptide Quantitation 38 4.4 Advantages of the
Diversity of Mass Spectrometry Systems 41 4.5 Perspectives for the Future
41 References 42 5 Peptide and Protein Bioanalysis Using Integrated
Column-to-Source Technology for High-Flow Nanospray 45 Shane R. Needham and
Gary A. Valaskovic 5.1 Introduction - LC-MS Has Enabled the Field of
Protein Biomarker Discovery 45 5.2 Integration of Miniaturized LC with
Nanospray ESI-MS Is a Key for Success 46 5.3 Micro- and Nano-LC Are Well
Suited for Quantitative Bioanalysis 47 5.4 Demonstrating Packed-Emitter
Columns Are Suitable for Bioanalysis 49 5.5 Future Outlook 51 References 52
6 Targeting the Right Protein Isoform: Mass Spectrometry-Based Proteomic
Characterization of Alternative Splice Variants 55 Jiang Wu 6.1
Introduction 55 6.2 Alternative Splicing and Human Diseases 55 6.3
Identification of Splice Variant Proteins 56 6.4 Conclusion 64 References
64 7 The Application of Immunoaffinity-Based Mass Spectrometry to
Characterize Protein Biomarkers and Biotherapeutics 67 Bradley L. Ackermann
and Michael J. Berna 7.1 Introduction 67 7.2 Overview of IA-MS Methods 69
7.3 IA-MS Applications - Biomarkers 74 7.3.1 Peptide Biomarkers 74 7.4
IA-MS Applications - Biotherapeutics 81 7.5 Future Direction 84 References
85 8 Semiquantification and Isotyping of Antidrug Antibodies by
Immunocapture-LC/MS for Immunogenicity Assessment 91 Jianing Zeng, Hao
Jiang, and Linlin Luo 8.1 Introduction 91 8.2 Multiplexing Direct
Measurement of ADAs by Immunocapture-LC/MS for Immunogenicity Screening,
Titering, and Isotyping 93 8.3 Indirect Measurement of ADAs by Quantifying
ADA Binding Components 95 8.4 Use of LC-MS to Assist in Method Development
of Cell-Based Neutralizing Antibody Assays 96 8.5 Conclusion and Future
Perspectives 97 References 97 9 Mass Spectrometry-Based Assay for
High-Throughput and High-Sensitivity Biomarker Verification 99 Xuejiang Guo
and Keqi Tang 9.1 Background 99 9.2 Sample Processing Strategies 100 9.3
Advanced Electrospray Ionization Mass Spectrometry Instrumentation 102 9.4
Conclusion 105 References 105 10 Monitoring Quality of Critical Reagents
Used in Ligand Binding Assays with Liquid Chromatography Mass Spectrometry
(LC-MS) 107 Brian Geist, Adrienne Clements-Egan, and Tong-Yuan Yang 10.1
Introduction 107 10.2 Case Study Examples 114 10.3 Discussion 122
Acknowledgment 126 References 126 11 Application of Liquid
Chromatography-High Resolution Mass Spectrometry in the Quantification of
Intact Proteins in Biological Fluids 129 Stanley (Weihua) Zhang, Jonathan
Crowther, and Wenying Jian 11.1 Introduction 129 11.2 Workflows for
Quantification of Proteins Using Full-Scan LC-HRMS 131 11.3 Internal
Standard Strategy 133 11.4 Calibration and Quality Control (QC) Sample
Strategy 135 11.5 Common Issues in Quantification of Proteins Using LC-HRMS
135 11.6 Examples of LC-HRMS-Based Intact Protein Quantification 137 11.7
Conclusion and Future Perspectives 138 Acknowledgment 140 References 140 12
LC-MS/MS Bioanalytical Method Development Strategy for Therapeutic
Monoclonal Antibodies in Preclinical Studies 145 Hongyan Li, Timothy Heath,
and Christopher A. James 12.1 Introduction: LC-MS/MS Bioanalysis of
Therapeutic Monoclonal Antibodies 145 12.2 Highlights of Recent Method
Development Strategies 146 12.3 Case Studies of Preclinical Applications of
LC-MS/MS for Monoclonal Antibody Bioanalysis 154 12.4 Conclusion and Future
Perspectives 156 References 158 13 Generic Peptide Strategies for LC-MS/MS
Bioanalysis of Human Monoclonal Antibody Drugs and Drug Candidates 161
Michael T. Furlong 13.1 Introduction 161 13.2 A Universal Peptide LC-MS/MS
Assay for Bioanalysis of a Diversity of Human Monoclonal Antibodies and Fc
Fusion Proteins in Animal Studies 161 13.3 An Improved "Dual" Universal
Peptide LC-MS/MS Assay for Bioanalysis of Human mAb Drug Candidates in
Animal Studies 165 13.4 Extending the Universal Peptide Assay Concept to
Human mAb Bioanalysis in Human Studies 170 13.5 Internal Standard Options
for Generic Peptide LC-MS/MS Assays 173 13.6 Sample Preparation Strategies
for Generic Peptide LC-MS/MS Assays 175 13.7 Limitations of Generic Peptide
LC-MS/MS Assays 177 13.8 Conclusion 178 Acknowledgments 178 References 178
14 Mass Spectrometry-Based Methodologies for Pharmacokinetic
Characterization of Antibody Drug Conjugate Candidates During Drug
Development 183 Yongjun Xue, Priya Sriraman, Matthew V. Myers, Xiaomin
Wang, Jian Chen, Brian Melo, Martha Vallejo, Stephen E. Maxwell, and Sekhar
Surapaneni 14.1 Introduction 183 14.2 Mechanism of Action 183 14.3 Mass
Spectrometry Measurement for DAR Distribution of Circulating ADCs 186 14.4
Total Antibody Quantitation by Ligand Binding or LC-MS/MS 189 14.5 Total
Conjugated Drug Quantitation by Ligand Binding or LC-MS/MS 193 14.6
Catabolite Quantitation by LC-MS/MS 196 14.7 Preclinical and Clinical
Pharmacokinetic Support 197 14.8 Conclusion and Future Perspectives 198
References 198 15 Sample Preparation Strategies for LC-MS Bioanalysis of
Proteins 203 Long Yuan and Qin C. Ji 15.1 Introduction 203 15.2 Sample
Preparation Strategies to Improve Assay Sensitivity 205 15.3 Sample
Preparation Strategies to Differentiate Free, Total, and ADA-Bound Proteins
213 15.4 Sample Preparation Strategies to Overcome Interference from
Antidrug Antibodies or Soluble Target 214 15.5 Protein Digestion Strategies
214 15.6. Conclusion 215 Acknowledgment 216 References 216 16
Characterization of Protein Therapeutics by Mass Spectrometry 221 Wei Wu,
Hangtian Song, Thomas Slaney, Richard Ludwig, Li Tao, and Tapan Das 16.1
Introduction 221 16.2 Variants Associated with Cysteine/Disulfide Bonds in
Protein Therapeutics 221 16.3 N-C-Terminal Variants 225 16.4 Glycation 226
16.5 Oxidation 226 16.6 Discoloration 228 16.7 Sequence Variants 230 16.8
Glycosylation 232 16.9 Conclusion 240 References 240 Index 251