As the pharmaceutical market in the United States and the rest of the world continues to expand, biopharmaceutical products have taken on increasing importance in the treatment of disease. From 2005 through 2015, the global pharmaceutical market has grown from approximately $6.5 billion to nearly $11 billion, driven in large part by the introduction of more and more monoclonal antibody products. Sales of this segment of the pharmaceutical market have grown at a compound annual growth rate of approximately 10% for the last 10 years making biologics approximately nearly 15% of the total pharmaceutical market. As more and more exciting monoclonal antibody products for treatment of cancer, autoimmune diseases, cardiovascular disease, and others are introduced, the growth of monoclonal antibodies is predicted to continue with expectations that sales of these products expected to reach almost $250 million by 2020.

When The Development of Therapeutic Monoclonal Antibodies was originally released in 2010, it quickly became an indispensable tool for those involved in the development or financing of monoclonal antibodies. It served as a guide to the complex technical, regulatory, and strategic Chemistry, Manufacturing, and Controls (CMC) activities necessary to successfully advance new monoclonal antibody products to clinical trials and the market as quickly as possible. This Second Edition has been fully revised and updated for 2016, with the addition of new content addressing advancements in Quality by Design (QbD), analytical development, and process validation, and more. Since publication of the First Edition of this book, regulatory agencies in the US, Europe, and the rest of the world have updated or issued all of the major guidances and regulations related to biopharmaceutical products. This new Second Edition includes a discussion of these new guidance documents from FDA, EMA, and ICH.

The Second Edition takes an updated look at, and provides recommendations for, all aspects of CMC necessary for the development of monoclonal antibody products from discovery through First In-Human Trials. The regulatory framework in which developers of monoclonal antibodies must operate is complex and constantly evolving. This report provides an overview of the most up to date regulatory thinking and the course that it may take going forward.

The Development of Therapeutic Monoclonal Antibodies Second Edition goes beyond other reports by incorporating the latest technical developments and integrating strategic and regulatory considerations with these technical requirements. This report will serve as a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.

Howard L. Levine, Ph.D.

Brendan R. Cooney

November 2016