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The Development of Therapeutic Monoclonal Antibody Products

Second Edition – June, 2017


View the Table of Contents, List of Tables and Figures, plus an excerpt from Chapter 1:


This report provides an overall roadmap for the development of therapeutic monoclonal antibody products. The report focuses on the technical, regulatory, and management issues related to process development, manufacturing, quality control, and analysis of full-length single specificity monoclonal antibody products produced in mammalian cell culture. The report provides a detailed analysis of the technical and regulatory requirements necessary to successfully develop therapeutic monoclonal antibody products from discovery through first-in-man clinical trials and also gives an overview of the strategic and regulatory considerations for late-stage development and commercialization of these products, including a detailed discussion of such important issues as process validation, Quality by Design, manufacturing economics, and the risks and benefits associated with the use of platform processes.

Reviews (2)

2 reviews for The Development of Therapeutic Monoclonal Antibody Products

Second Edition – June, 2017

  1. Al Doig

    “‘The Development of Therapeutic Monoclonal Antibody Products’ is essential reading for biotech executives from the C-suite to senior operations personnel. It gives a clear, concise, and authoritative overview of the many CMC challenges that must be addressed to produce an antibody treatment that will meet regulatory muster and advance through clinical trials to ultimately help patients. Our regulatory and production team refers often to this book.” David de Graaf, Ph.D., president and chief executive officer of Syntimmune

  2. Al Doig

    “BPTC is to be applauded for this new, expanded edition of ‘The Development of Therapeutic Monoclonal Antibody Products.’ In addition to providing companies with useful information that will enable them to speed their drug candidates through the many chemistry and manufacturing issues that will arise on the road to commercialization, the book will be an invaluable reference and teaching tool for those new to the field of monoclonal antibody development.”
    Anthony J. Sinskey, Sc.D., professor of microbiology and engineering systems at the Massachusetts Institute of Technology

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