The determination of product critical quality attributes (CQAs), key process parameters and indicators (KPPs and KPIs respectively) is a critical step for process efficiency during cell line development. Thousands of clones are typically screened with the goal of finding those that are stable, produce high yields of the bioproduct and exhibit desired CQAs. Screening and process optimization activities are typically carried out at the small scale in bioreactor cultures and are aimed at ensuring that results translate to larger bioreactor scales. Performance monitoring is primarily based on cell growth, cell viability, metabolite analysis and product titer, and is assessed over the entire culture process duration.

Octet® BLI instruments utilize the biolayer interferometry (BLI) technology to monitor response changes upon the interaction of biological molecules. They can be easily implemented in cell line development labs to facilitate rapid determination of product yield amongst other attributes. Implementing state-of-the-art analytical technologies into the cell culture process development workflow can greatly reduce time to results. This capability allows informed decisions directly at the end of the process. It also enables subsequent experiments to be planned based on all of the performance data, rather than waiting days or weeks for product yield and other attributes data to be available. In this poster we show the power of using the Ambr® 15 Cell Culture system with an integrated Vi-CELL XR and Ambr® Analysis Module together with an Octet® R8 instrument to identify optimum yield conditions in media screening and process optimization experiments.