S16: Technology improvements to accelerate process development of biologicals

Pressures continue to reduce the time from discovery to product launch and minimize the costs of not only manufacturing but also process development.  This is particularly difficult for upstream development where large DOE designs in lab scale reactors, provides a significant equipment and resource constraint. The presentation will show how innovation through automation and single-use technology has led to more efficient process development.  This includes the creation of multi use tools to handle both cell culture and microbial expression platforms.  Improvements will be shown for end to end development focusing on upstream processing followed by purification and analytics.  Examples include the use of cell line development automation for the elimination of manual shakeflask stages and increase throughput of clonal evaluation.  For more advanced process development a novel small scale single use prototype bioreactor is evaluated.  This system is designed for automated multi tank experimentation with robotic sampling, feeding and control.  This is integrated with high throughput purification and analytics using a systematic approach of statistical design of experiments in combination with 'omics' technologies. This allows for a rapid end to end process development and builds a fundamental understanding of the impact of process operations to control process consistency and product quality.