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New chemically defined platform media (basal and feed) were developed by leveraging data and knowledge from the two Genentech and Roche legacy platform processes, and through a series of experiments including high-throughput systems for cell culture, shake flasks, 2L bioreactors and pilot-scale bioreactors. An average increase in final titer of 30% was achieved compared to the two legacy platforms.  The final process resulted in product quality attributes (glycans, charge variants, size) that were comparable to historical data. No new variants were detected. The final and fully harmonized platform process is specified and implemented.

Development and implementation of a global Roche cell culture platform for production of monoclonal antibodies