ABSTRACT
Animal cell culture processes have been used for more than a decade to produce protein products for therapeutic use (1). As this technology has advanced, practitioners have identified paradigms for process design, monitoring, and validation to ensure consistent production of the desired product. This chapter outlines the approach taken at Genetics Institute (GI) for the validation of a number of commercial animal cell culture processes and the rationale behind our validation plan. The primary focus is on animal cell culture rather than downstream processing, which is dealt with in another chapter of this book (Chapter 3).
