Monday, July 27, 2009
P10

Challenges with maintaining comparable product quality throughout process development: A Non-Antibody CHO cell culture process case study

Adam Winchester, Minh Luu, Kara Calhoun, Steven Meier, and Bob Kiss. Late Stage Cell Culture, Process Research & Development, Genentech, 1 DNA Way, South San Francisco, CA 94080

Cell culture development comes with challenges not the least of which is maintaining consistent product quality while striving to increase culture productivity. Through all phases of development, it is important to understand how adjustments to culture conditions can affect product quality attributes. A specific case study will be reviewed outlining the effects of media components and cell culture parameters on overall sialic acid and mannose phosphate content for a non-antibody therapeutic protein.