Monday, July 30, 2007 - 8:30 AM
S2
Effects of Culture Conditions on Protein Quality: Job Security for Cell Culture Engineers
Robert D. Kiss, Late Stage Cell Culture Process Development, Genentech, Inc., 1 DNA Way, MS 32, South San Francisco, CA 94080
In producing therapeutic proteins from cell culture processes, it is necessary to develop processes capable of delivering consistent protein characteristics, particularly those that could affect the structure or function of the biomolecule. Over the past twenty years, Genentech cell culture scientists and engineers have navigated the waters of process understanding in tackling product quality challenges involving topics such as glycosylation (micro and macroheterogeneity), deamidation, aggregation, and charge variant distributions. In most cases, the root cause of product quality variation was typically related to cell culture process conditions. This presentation will review this experience and discuss approaches toward better understanding and control of recombinant protein product characteristics through cell culture manipulations including medium composition and processing factors.