Monoclonal Antibodies: A Comprehensive Guide to Physiochemical Testing and Characterization

Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules that have been engineered into a leading therapeutic modality for addressing immunotherapeutic challenges. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. However, developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations 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.

Physiochemical Aspects of Monoclonal Antibodies

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.

Antibody Heterogeneity

Antibody heterogeneity in terms of size, charge, and carbohydrate content is a critical aspect of mAb development. This book provides a comprehensive overview of the various analytical tests and characterization methods necessary for developing and releasing mAb batches, ensuring that scientists have a thorough understanding of the complexities involved.

Structural Analysis of Monoclonal Antibodies

The structural analysis of mAbs, including mass spectrometry analysis, is a key component of this book. By presenting the basic structure of mAbs with clarity and rigor, scientists can gain a deeper understanding of the molecular mechanisms underlying mAb function and develop more effective therapeutic strategies.

Regulatory Guidelines

This book also addresses regulatory guidelines – including ICH Q6B – in relation to quality attributes, providing scientists with the necessary information to ensure compliance with international standards and regulations. This is particularly important for researchers working on biosimilars and new antibody formats, where regulatory requirements can be complex and challenging to navigate.

Case Studies

Finally, the book presents characterization and development case studies including biosimilars and new antibody formats, offering practical insights and real-world examples of how mAb development can be successfully achieved. These case studies provide valuable lessons for scientists working in this field, helping them to overcome common challenges and develop effective therapeutic strategies.