Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing and Preclinical and Clinical Development

This book guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs. Flow charts, tables, and figures clearly illustrate the processes and allow for an easy and comprehensible read. It discusses the scientific background including history, classification, and biological activities. Coverage of receptors provide important background knowledge unique to mAb drugs and essential profiling characteristics that regulations require for biosimilar mAb development. Chapters address the processes and issues involved with manufacturing biosimilar mAbs, like cell line development, process development, large-scale cell culture of mammalian cells, and final product analysis. Readers are introduced to topics of bioanalytical development, preclinical and clinical validation of biosimilarity, regulatory issues, and legal considerations concerning approval and commercialization. Lastly, this book leads readers to think beyond biosimilars by examining new technologies and strategies for improving biosimilar mAbs.