Advances in the development of therapeutic monoclonal antibodies

Monoclonal antibodies (MAbs) and related products are a dominant component of the biopharmaceutical market, generating revenues of several billion dollars. While MAbs have proven to be valuable therapeutic products, the typical doses of these products required for treatment are significantly higher than those required for most other biologic products, resulting in the need for large-scale production and efficient, cost-effective manufacturing processes. In the past few years, improvements have been made In critical areas, such as cell line generation and large-scale cell culture production, to maximize productivity. These advances, coupled with Improvements in cell culture media and optimized bioreactor processes, have made large-scale production of MAbs economically viable. However, the increasing production requirements and the drive to reduce the cost to develop these expensive medicines continue to present challenges to the industry to further improve the overall efficiency of manufacturing processes. This article presents a historical review of the discovery, development, and production of therapeutic antibodies.