Liu C., Morrow K.J. (eds.) Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development

John Wiley & Sons, Inc, 2017. — 704 p. — ISBN: 1118662318.Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs.
Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible.
Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information.
Examines new technologies and strategies for improving biosimilar mAbs.The History of Therapeutic Monoclonal Antibodies.
Structure, Classification, and Naming of Therapeutic Monoclonal Antibodies.
Mechanism of Action for Therapeutic Antibodies.
Therapeutic Monoclonal Antibodies and Their Targets.
Antibody Posttranslational Modifications.
The Pharmacology, Pharmacokinetics, and Pharmacodynamics of Antibodies.
Monoclonal Antibodies: Applications in Clinical Oncology.
Development of Biosimilar Rituximab and Clinical Experience.
Monoclonal Antibodies for Infectious Diseases.
Monoclonal Antibodies for Musculoskeletal, CNS, and Other Diseases.
Manufacture of Recombinant Therapeutic Proteins Using Chinese Hamster Ovary Cells in Large‐Scale Bioreactors: History, Methods, and Perspectives.
Process Development.
Biosimilars and Biobetters: Impact on Biopharmaceutical Manufacturing and CMOs.
Cell Line and Cell Culture Development for Biosimilar Antibody‐Drug Manufacturing.
Product Analysis of Biosimilar Antibodies.
Bioanalytical Development.
Preclinical and Clinical Development of Biosimilar Antibodies.
Regulatory Issues.
Legal Considerations.
ADCC Enhancement Technologies for Next‐Generation Therapeutic Antibodies.
Antibody Half‐Life: Engineering for Optimal Performance.
Technologies for Antibody‐Drug Conjugation.