Streamlining the Discovery to Development Transition

State of the art expression technologies now allow routine production of recombinant protein therapeutics at levels adequate to support clinical testing and commercialization. However, identification of satisfactory production cell lines remains a tedious, resource costly, and time consuming process. Strategies to increase the efficiency of this process without compromising quality are clearly needed. To achieve more rapid cell line development we have taken a number of steps at Pfizer including 1) earlier engagement with Discovery organizations to harmonize production systems, 2) implementation of a molecule assessment to identify molecule liabilities at an early stage, and 3) implementation of site-specific integration technology to allow more consistent stable expression. These steps have enabled accelerated development; in one case resulting in the manufacturing of a master cell bank within three months of the identification of the final clinical candidate. This presentation will highlight the coordination of these technologies to allow accelerated development of protein therapeutics derived from diverse Discovery organizations and partners.