(74e) Redefining Cell Line Optimization and Process Optimization: Using 10 Ml “High-Throughput” MicroBioreactors

A key factor for reducing timelines and resource demands for biopharmaceutical organizations is the successful early stage development of cell lines and processes that will meet the demands of a commercial launch and ultimately benefitting the patient. Cell lines and processes historically were initially developed in uncontrolled environments (T-flasks and Shake Flasks) that poorly modeled bioreactors (commercial method of production) and not until late in development were cells placed in controlled bioreactor environments. Developing processes uncontrolled has risks associated with it; for instance, selecting cell lines that respond to feeds in uncontrolled environments but not under controlled conditions, thus causing additional work in cell line selection and/or process optimization. The decision to screen uncontrolled in the past was based often on resource limitations (bioreactors, number of clones, cost) not on whether it was the best way to screen or develop commercial ready products. The Micro-24? MicroBioreactor is a 24 well system with individual pH, DO, and temperature control which allows users to maximize the likelihood of obtaining a ?winning? cell line prior to commercialization. Data will be presented showing the Micro-24? MicroBioreactor being utilized successfully in cell line selection activities (ranking clones) and process optimization (parameter optimization) activities and its scalability to larger bioreactors, demonstrating the advantages of a controlled ?high-throughput? bioreactor system that allows rapid, very early stage process development which can contribute to shorter development timelines and lower development costs.