CMC Activities for Development of MAbs: Critical steps to reach IND with a therapeutic antibody
The current economic crisis combined with increasing competition and the need to make healthcare more affordable present formidable challenges to today’s biopharmaceutical industry. By 2015, spending on prescription medicines in the United States alone is forecast to be approximately $450 billion or greater than 10% of all US healthcare expenditures. Biologic products already account for almost 15% of the total market for pharmaceutical products. Spending on these products is expected to continue to grow in the coming years, with monoclonal antibody products being the fastest growing segment of biologic products.
BioProcess Technology Consultants recently published The Development of Therapeutic Monoclonal Antibody Products report which is an indispensable guide to the complex technical, regulatory, and strategic Chemistry, Manufacturing, and Control (CMC) activities necessary to successfully advance new monoclonal antibody products to clinical trials and the market as quickly and economically as possible. This article is a summary of Chapter 3, “Overview of CMC Activities for Monoclonal Antibody Development,” which provides a synopsis of the key CMC development functions:
- Analytical Method Development
- Upstream Process Development
- Downstream Process Development
- Formulation Development
- Scale-up and Bulk Drug Substance Manufacturing
- Final Drug Product Manufacturing (Fill/Finish).