Transgenic Technology for Monoclonal Antibody Production

Abstract

Monoclonal antibodies account for between one-third and one-half of all pharmaceutical products in development and in human clinical trials. Both the nature of monoclonal antibody therapies, and the relatively large size of the monoclonal antibody molecules dictate that the production requirements for many of these therapeutic monoclonal antibody products will be 100 kilograms or more per year. It is widely acknowledged that there is currently a worldwide shortage of biomanufacturing capacity, and that the gap between biomanufacturing capacity and the active pharmaceutical ingredient material requirements for these products is expected to increase.