Monoclonal Antibodies: Physicochemical Analysis

Monoclonal antibodies (mAbs) are a powerful therapeutic modality, but developing them into well-characterized antibody therapeutics is challenging. This book discusses the structure and physiochemical testing and characterization methods needed to establish a mAb as a therapeutic molecule, focusing on quality attributes such as glycosylation, primary sequence, purity, and higher-order structure.

Format: Paperback / softback
Length: 258 pages
Publication date: 06 August 2021
Publisher: Elsevier Science Publishing Co Inc

Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules that have undergone a remarkable transformation through innovative engineering techniques. These remarkable molecules have emerged as a leading therapeutic modality, revolutionizing the field of immunotherapeutics. As the dominant class of protein therapeutics, mAbs have demonstrated immense potential in developing safe and effective treatments for complex diseases, offering more affordable healthcare solutions.

However, the development of well-characterized antibody therapeutics that meet regulatory expectations poses significant challenges. These challenges include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book delves deep into the structure of mAbs, exploring the array of physiochemical testing and characterization methods that are necessary to establish a mAb as a therapeutic molecule.

The primary focus of this book is on the physiochemical aspects of mAbs. It emphasizes the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS. By elucidating these quality attributes, scientists can gain valuable insights into the structure and function of mAbs, enabling them to develop biopharmaceuticals and biosimilars that address physicochemical testing and characterization challenges.

In this comprehensive book, each of the aforementioned quality attributes is discussed in detail. The authors provide a thorough understanding of the principles and methodologies involved in physicochemical testing and characterization, enabling scientists to develop robust and reliable methods for evaluating the quality and safety of mAbs. The book also explores the structure of new antibody formats, such as bispecific antibodies and antibody-drug conjugates, using advanced mass spectrometry techniques.

By leveraging the knowledge and insights gained from this book, scientists will be well-equipped to research and develop biopharmaceuticals and biosimilars that meet the rigorous standards of physicochemical testing and characterization. The development of these innovative therapies will have a profound impact on healthcare, enabling patients to receive safe and effective treatments for a wide range of diseases.

In conclusion, Monoclonal Antibodies: Physicochemical Aspects and Quality Attributes is a valuable resource for scientists, researchers, and healthcare professionals involved in the field of immunotherapeutics. It provides a comprehensive and in-depth exploration of the structure, physiochemical testing, and characterization methods of mAbs, enabling scientists to develop safe and effective treatments for complex diseases and create more affordable healthcare alternatives.

Weight: 430g
Dimension: 229 x 152 (mm)
ISBN-13: 9780128223185