Advances in cell culture process development: tools and techniques for improving cell line development and process optimization.

At the 234th National Meeting of the American Chemical Society, held in Boston, MA, August 19-23, 2007, the ACS BIOT division held two oral sessions on Cell Culture Process Development. In addition, a number of posters were presented in this area. The critical issues facing cell culture process development today are how to effectively respond to the increase in product demands and decreased process timelines while maintaining robust process performance and product quality and responding to the Quality by Design initiative promulgated by the Food and Drug Administration. Two main areas were addressed in the presentations: first, to understand the effects of process conditions on productivity and product quality, and second, to achieve improved production cell lines. A variety of techniques to achieve these goals were presented, including automated flow cytometric analysis, a high-throughput cell analysis and selection method, transcriptional and epigenetic techniques for analysis of cell lines and cell culture systems, and novel techniques for glycoform analysis.