(307d) Improving Platform Process Feeding Strategy Using an Ivcc-Based Approach for CHO-M Cell Lines

Development of fed-batch cell culture processes for biologics production includes optimization of feed medium addition. Fed-batch culture performance including metabolite levels and productivity can be influenced with different feed strategies. Traditional approaches for feed addition include percent-based additions considering initial or current bioreactor working volumes. These are empirical methods based on platform processes and may not fully represent per cell nutrient requirement. We have developed a platform feeding strategy, which is based on the integrated viable cell concentration (IVCC). Using a commercially available feed medium with our platform process we tested 2 cell lines to determine percent feed additions based on IVCC. For subsequent experiments, percent feed additions were fixed based on the IVCC experiments. This approach allows to adjust nutrient levels depending on cell growth and develop a feedback loop. Given the need for Speed to IND, optimization of feed strategies specific to each cell lines may not be feasible. Thus, we’ve developed a feed addition approach based on the IVCC-based experiments and are applying toward updating the platform process for process development and manufacturing. This has ensured an improvement in feeding strategy compared to the empirical approach while keeping the manufacturing process operationally simple.