(194d) Development of An Animal Component-Free Cell Culture Process

Use of animal component-free cell culture media for the production of recombinant proteins would address regulatory and safety concerns associated with the presence of complex raw materials in cell culture processes. Various approaches were taken through process development efforts to remove an animal-derived peptone, Peptone A, from the cell culture process for a specific antibody. Process development methods included substitution of Peptone A with alternative animal-component free hydrolysates, as well as development of a chemically defined process. Changes were made to media components and process conditions in order to achieve cell culture performance and titer comparable to the peptone-containing process for this antibody. Performance parameters such as cell growth, viability, metabolites, titer, cell cycle and apoptosis levels were monitored throughout production. Spent media was also analyzed for the various conditions to screen for potential limiting components of the peptone-free conditions. The various approaches taken for cell culture process development of an animal component-free process will be discussed.