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Figure 1. Schematic of an antibody. Pfizer’s developmental compound tremelimumab is an antibody of subclass IgG2 and is composed of four proteins linked by disulfide bonds. Many antibodies are glycosylated, meaning that polysaccharide structures are covalently attached to the proteins at distinct sites. An antibody can have several domains that have activity, including the variable regions on the arms of the heavy and light chains, which bind to antigens, and the Fc domains, which can mediate effector functions. Adapted with permission from Pfizer, Inc.

http://www.sciencedirect.com/science/article/pii/S1359644608001475

The art of antibody process development

Volume 13, Issues 13–14, July 2008, Pages 613–618

• David E. Steinmeyer^, , 
• Ellen L. McCormick
  

• Global Biologics, Pfizer Global Research & Development, Chesterfield, MO, United States
• Biopharmaceutical drug development is an intricate path that spans a dozen years from discovery through registration. The development of a therapeutic antibody presents substantial challenges, particularly with respect to the creation and implementation of manufacturing process technologies. Process development and large scale biotherapeutic manufacturing is an art generally only practiced within industry. As a consequence, these technologies may be seen as something of a ‘black box’ by many in the medical community. This article provides insight into the current art of antibody process development leading to market entry of novel, life-saving medicines.
• http://www.sciencedirect.com/science/article/pii/S1359644608001475

• http://dx.doi.org/10.1016/j.drudis.2008.04.005,