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.
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 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.
Key Topics Covered:
Chapter 1: The Therapeutic Monoclonal Antibody Market
Chapter 2: Overview of Chemistry, Manufacturing, and Control Activities for Monoclonal Antibody Product Development