Facility Design and Validation Considerations for Continuous Cell Culture Processes

Abstract

There is growing interest in the use of continuous cell culture processes for the production of mammalian cell derived products. Although batch and fed batch operations still predominate, an increasing number of fIrms are looking to continuous production techniques due to their inherent advantages over batch. After a brief review of those advantages, I ‘ll focus on two key items of paramount importance in the implementation of a continuous cell culture process: facility design and process validation.