Traversing Six Logs in Scale-Down Modeling: Two Case Studies in Developing a Scale-Down Model for the Advanced Microscale Bioreactor System From a 15,000L Production Bioreactor

Traversing six logs in scale-down modeling:  two case studies in developing a scale-down model for the advanced microscale bioreactor system from a 15,000L production bioreactor

The use of TAP Biosystem's advanced microscale bioreactor system (AMBR) has gained popularity in recent years as a high throughput cell culture process development tool.  The following presents two case studies in which a scale-down model was developed from 15,000L production bioreactor data and scaled down to the 15mL AMBR using specific scale-down methodologies and strategies.  Multivariate data analysis was then performed on representative data across AMBR, bench top, pilot, and manufacturing scales to demonstrate comparability across the scales.  We will highlight the major variations across scales and discuss their contributions to cell culture performance and product quality.  We will also discuss the methods and strategies used to develop the scale-down model in addition to operational problems and successes using the AMBR system as a cell culture process development tool.