Monoclonal 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

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Yes, you can access Monoclonal Antibodies by Harleen Kaur, Dietmar Reusch, Harleen Kaur,Dietmar Reusch in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

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Cover
Title page
Table of Contents
Copyright
Dedication
Contents
List of contributors
Preface
Acknowledgment
List of Illustrations
List of Tables
Chapter 1 : Overview of monoclonal antibodies
Chapter 2 : Physicochemical characterization of monoclonal antibodies
Chapter 3 : Glycosylation analysis
Chapter 4 : Primary structure and peptide mapping
Chapter 5 : Separation techniques for characterization and quantification of monoclonal antibody purity
Chapter 6 : Higher order structure and free thiol
Chapter 7 : Advanced structural elucidation of new antibody formats by mass spectrometry
Index
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Table of contents