The cell culture pilot plant at Genentech runs hundreds of E. coli fermentation experiments to help develop part of the company’s pipeline. The pilot plant is a non-GMP facility that supports process development and evaluating new technologies that can be transferred into our manufacturing network. The E. coli experiments are continuously sampled every two hours, 24/7, resulting in approximately 20,000 E. coli samples a year. Evaluating an “at-line real-time analyzer” for E. coli fermentations that would be implemented to replace manual bench-top operations could significantly increase efficiency and improve data integrity. A key challenge with incorporating new innovative technology is correlating analytical results between the existing test methods and the new automated process. In addition to assessing method comparability data, understanding the ROI for implementing new technologies is critical to conduct thorough evaluations.
In this GEN webinar, our panelists will describe their approach to evaluating the Cedex Bio/Bio HT analyzers for E. coli fermentation, and their impact on turnaround time and cost of analysis. The analyzer measures phosphate, acetate, ammonia, glucose, and optical density, as well as other parameters with high precision and accuracy for monitoring cell growth and metabolic levels for process development.