Biosimilars Of Monoclonal Antibodies: A Practical Guide To Manufacturing, 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.

Cheng Liu, PhD, is founder and CEO of Eureka Therapeutics, a biotech company dedicated to monoclonal antibody drug discovery and development for unmet medical needs. He is an expert on therapeutic antibody and engineering, and a frequent speaker at pharmaceutical conferences. In 2007, Dr. Liu was awarded Special Congressional Recognition for his contributions to improving human health.

K. John Morrow, Jr., PhD, is President and CEO of Newport Biotechnology Consultants, a consultant for Meridian Bioscience, and on the adjunct faculty of Northern Kentucky University. He has over 60 peer-reviewed publications and serves on the editorial boards of Biopharm International and the International Journal of Biotechnology for Wellness Industries.