Whole-Genome Evolution Technology: Improving Protein And Antibody Yields In Scalable Mammalian-Cell-Based Manufacturing

By J. Bradford Kline, Qimin Chao, Yuhong Zhou, Eric L. Routhier, Wolfgang Ebel, Steven A. Feldman, Philip M. Sass, Luigi Grasso, and Nicholas C. Nicolaides

Over the past decade, therapeutic proteins and monoclonal antibodies (MAbs) have become one of the most successful classes of pharmaceutical agents because they can replace or block specific targets associated with disease (1). With the successful market performance of commercial products such as Remicade, Rituxan, Herceptin, Humira, and Avastin, MAbs have emerged as an important drug class, now representing about half of all new drug launches. Of all those launched to date, 40% are blockbuster drugs or have blockbuster revenue potential. Global sales of therapeutic MAbs exceeded $10 billion in 2004 and are projected to be in excess of $30 billion by 2008 (2). In the next five years, this should continue to be the fastest growing and most lucrative sector of the biotechnology and pharmaceutical industries — driven by technological evolution from chimeric (part human and part mouse) to humanized (CDRgrafted) to fully human antibodies.

Reprinted with permission from BioProcess International 4(5):S42-S47 (May 2006)