Monoclonal Antibodies
Physicochemical Analysis
- 1st Edition - August 3, 2021
- Imprint: Academic Press
- Editors: Harleen Kaur, Dietmar Reusch
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 2 3 1 8 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 2 2 3 1 9 - 2
Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing im… Read more
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Request a sales quoteMonoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS).
This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization.
- Describes the spectrum of analytical tests and characterization methods necessary for developing and releasing mAb batches
- Details antibody heterogeneity in terms of size, charge, and carbohydrate content
- Gives special focus to the structural analysis of mAbs, including mass spectrometry analysis
- Presents the basic structure of mAbs with clarity and rigor
- Addresses regulatory guidelines - including ICH Q6B - in relation to quality attributes
- Lays out characterization and development case studies including biosimilars and new antibody formats
Researchers in the pharmaceutical sciences as well as industrial pharmaceutical scientists; Researchers on biosimilars; Microbiologists, biochemists.
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- List of contributors
- Preface
- Acknowledgment
- Chapter 1. Overview of monoclonal antibodies
- Abstract
- 1.1 Introduction
- 1.2 Discovery of monoclonal antibodies
- 1.3 Structure of monoclonal antibody
- 1.4 Therapeutic applications of monoclonal antibodies
- 1.5 Conclusions
- References
- Further reading
- Chapter 2. Physicochemical characterization of monoclonal antibodies
- Abstract
- 2.1 Introduction
- 2.2 Identification of critical quality attributes
- 2.3 Glossary
- References
- Chapter 3. Glycosylation analysis
- Abstract
- 3.1 Introduction
- 3.2 Biological effects of different glycoforms of monoclonal antibodies
- 3.3 Pharmacokinetic effects of different glycoforms of monoclonal antibodies
- 3.4 Characterization of monoclonal antibody glycosylation
- 3.5 O-glycosylation of monoclonal antibodies
- 3.6 Conclusion
- References
- Chapter 4. Primary structure and peptide mapping
- Abstract
- 4.1 Introduction
- 4.2 Peptide mapping
- 4.3 Mass spectrometry
- 4.4 Conclusion
- References
- Further reading
- Chapter 5. Separation techniques for characterization and quantification of monoclonal antibody purity
- Abstract
- 5.1 Introduction and overview
- 5.2 Size-exclusion chromatography
- 5.3 Charge-based separation methods
- 5.4 Capillary electrophoresis sodium dodecyl sulfate separation
- 5.5 Hydrophobicity-based separation methods
- 5.6 Affinity-based separation methods
- 5.7 Hyphenation of separation methods and detection by mass spectrometry
- 5.8 Conclusion and summary
- References
- Chapter 6. Higher order structure and free thiol
- Abstract
- 6.1 Introduction
- 6.2 Nuclear magnetic resonance
- 6.3 Fourier transform infrared spectroscopy and Raman spectroscopy
- 6.4 Fluorescence spectroscopy
- 6.5 Free thiol analysis
- References
- Chapter 7. Advanced structural elucidation of new antibody formats by mass spectrometry
- Abstract
- 7.1 Introduction
- 7.2 Product attributes and the applied methods for their characterization
- 7.3 Limitations of the analytical toolbox
- 7.4 The emerging role of mass spectrometry
- 7.5 Two-/multidimensional LC as a complementary tool to characterize bio-therapeutics
- 7.6 Conclusion
- References
- Index
- Edition: 1
- Published: August 3, 2021
- No. of pages (Paperback): 258
- No. of pages (eBook): 258
- Imprint: Academic Press
- Language: English
- Paperback ISBN: 9780128223185
- eBook ISBN: 9780128223192
HK
Harleen Kaur
Dr. Harleen Kaur research focuses on the development and characterization of large molecules, particularly monoclonal antibodies (mAbs) and bringing therapeutic molecules from early discovery and research stage to commercialization. Dr Kaur has previously worked for AstraZeneca and WuXi Biologics in the United States and has extensive experience in the development and testing of biologics as therapeutic molecules in a highly regulated environment. She earned her undergraduate degree from Guru Gobind Singh Indraprastha University, India, and PhD degree from the National University of Singapore, Singapore. Dr Kaur is the author of many peer-reviewed publications and book chapters in the area of antibody characterization and aptamers. She is also the lead editor of the book titled “Monoclonal Antibodies: Physicochemical Analysis” that was published by Elsevier.
DR
Dietmar Reusch
Dietmar Reusch, PhD, is affiliated with Roche Diagnostics GmbH in Germany. His research focuses on the analytical development and characterization of large molecules, particularly mAbs, and on bringing therapeutic products from entry into human to commercial launch.
Affiliations and expertise
F. Hoffmann-La Roche AG, München, GermanyRead Monoclonal Antibodies on ScienceDirect