The Development of Therapeutic Monoclonal Antibody Products
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.