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The Development of Therapeutic Monoclonal Antibody Products

March 2018 Insight Pharma Reports


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. Sales of monoclonal antibody products have grown from approximately $50 billion in 2010 to almost $90 billion in 2015, an approximately 1.8‑fold increase and represent approximately 58% of biopharmaceutical sales.  As more and more exciting monoclonal antibody products for treatment of cancer, autoimmune diseases, cardiovascular disease, and others are introduced, sales from new products approved in the coming years will drive the world-wide sales of monoclonal antibody products to approximately $110 billion by 2018 and nearly $150 billion by 2021.

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 2017, to provide a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medicinal Product Dossier (IMPD) or equivalent for first in human clinical trials. The primary focus of the report remains 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. New to the Second Edition are an in-depth look at Quality by Design (QbD) for monoclonal antibodies in an all new chapter, an entirely new perspective on cell line development and engineering, a fresh look at process validation in line with current regulatory thinking, and updates aligning the content with today’s philosophies and practices throughout.

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.



About the Author(s):


Howard L. Levine, Ph.D., President and CEO of BioProcess Technology Consultants, Inc. (BPTC), is a pioneer and thought leader in the biopharmaceutical industry with extensive strategic and operational experience in biopharmaceutical product development and commercialization. In his more than 35 years in the biopharmaceutical industry Dr. Levine has assisted numerous companies in developing biological products, provided strategic input in the development of new manufacturing technologies, and participated in the successful commercialization of several of these products. Prior to founding BioProcess Technology Consultants in 1994, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation and previously held positions of increasing responsibility in process development and manufacturing at Genentech, Amgen, and Xoma.


Brendan R. Cooney, Associate Consultant of BioProcess Technology Consultants, Inc., has over eight years of experience as a technical and science writer in the pharmaceutical industry and academia. He has been involved in developing and writing document guidance systems and internal documentation systems for both research and commercial applications. Prior to working for BioProcess Technology Consultants, Brendan founded and ran CBRC Consulting, which provided technical writing consulting services to biotech companies including Shire HGT and Histogenics Corporation. He was awarded a B.A., magna cum laude, from Northeastern University in Boston, Massachusetts.