Current Therapeutic Antibody Production and Process Optimization

by Feng Li, PhD, Brian Lee, PhD, Joe X. Zhou, PhD, Tim Tressel, PhD, and Xiaoming Yang, PhD
Volume 5, Issue 4 (Winter 2006)

In today’s biopharmaceutical pipeline, monoclonal antibodies are a predominant modality for a broad range of clinical indications, including inflammatory disorders, oncology, and infectious diseases. More than two dozen antibody-based products are commercially available. In 2004, six of the 12 new biopharmaceutics that gained approval in the United States and Europe were antibody-based products. Most antibody therapies require high doses over a long period of time, which requires large amounts of purified product per patient. Therefore, manufacturing capacity to meet the demands of antibody production is a real challenge. It is desirable to have highly productive and consistent manufacturing processes. In addition, speed to market is critical to deliver health benefits to patients quickly and to achieve business success…

Li F, Lee B, Zhou JX, Tressel T, Yang X. Current Therapeutic Antibody Production and Process Optimization. BioProcess J, 2006; 5(4): 16-25.