Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (m Ab) 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 (m Ab) drugs
* Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible
* Includes a review of FDA-approved m Ab drugs as a quick reference to facts and useful information
* Examines new technologies and strategies for improving biosimilar m Abs
关于作者
Cheng Liu, Ph D, 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. He holds multiple issued US and international patents in the field of therapeutic antibody discovery and engineering and has authored many scientific publications in the field of cancer immunotherapy. Dr. Liu was awarded Special Congressional Recognition for his contributions to improving human health in 2007.
K. John Morrow, Jr., Ph D, is President and CEO of Newport Biotechnology Consultants, and has worked in academia and in the private sector. He has published a total of over 280 peer-reviewed articles, reports in biotechnology trade papers, chapters in books, and full length books. He serves as a consultant for Meridian Bioscience, Inc., in Cincinnati, OH and for Point A Consulting in Louisville, KY.
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