Molecules expressed in mammalian cells such as antibodies are the most widely used modality of biological therapeutics. Companies engaged in repeated development of these molecules have established process platforms that allow for rapid and predictable development, seamless transfers between facilities and sites, and ultimately enable them to quickly reach clinical and later commercials stages with a high success rate.
The inherent challenge by using the same, well-defined platform approach over and over again is to neglect technological opportunities, overlook improvements from competitors, or become inflexible to adjust to new regulatory expectations. 
We will discuss Amgen’s approach to keep our process platforms flexible yet provide sufficient guidance to achieve a high development success rate with very predictable development timelines.  We will further discuss our approach to phase-appropriate platform development and explain how continuous technology development can be incorporated into a platform to frequently rejuvenate it.