Monoclonal antibodies (mAbs) are naturally complex biomolecules. New engineering methods have set up mAbs as the leading therapeutic modality for addressing immunotherapeutic challenges. Monoclonal antibodies have great potential in the development of safe and reliable treatments for complex diseases, and for creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to be overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, purity, charge variants, carbohydrate structure, and higher-order structure. Monoclonal Antibodies: Physicochemical Analysis outlines the structure of mAbs, and the array of physiochemical testing and characterization methods that need to be developed and validated in order to establish a monoclonal antibody as a therapeutic molecule. The main focus of the book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation content, primary sequence, purity, size, and higher-order structure. This book presents a comprehensive overview of mAbs, one that will help scientists researching and developing biopharmaceuticals and biosimilars find practical solutions to physiochemical testing and characterization. Describes the spectrum of analytical tests and characterisation methods necessary for developing and releasing monoclonal antibody (mAb) batchesDetails antibody heterogeneity in terms of size, charge and carbohydrate contentGives special focus to the structural analysis of mAbs, including mass spectrometry analysisPresents the basic structure of monoclonal antibodies with clarity and rigorAddresses regulatory guidelines - including ICH Q6B - in relation to quality attributesLays out characterisation and development case studies including of biosimilars and new antibody formats INDICE: 1. Overview of Monoclonal Antibodies2. Physicochemical Characterisation of Monoclonal Antibodies3. Glycosylation4. Primary Sequence5. Size and Purity6. Higher Order Structure and Free Thiol7. Advanced structural elucidation of new antibody formats by mass spectrometry
- ISBN: 978-0-12-822318-5
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 225
- Fecha Publicación: 01/08/2021
- Nº Volúmenes: 1
- Idioma: Inglés