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.  Extensive vessel characterization and scale down modeling efforts have been explored industry-wide to assess the utility and drawbacks of such a system. In order to fully assess the system, we performed scale-down modeling from 15,000L production bioreactor to 15mL AMBR. Multivariate data analysis (MVDA) using SIMCA P+ was performed to demonstrate comparability between AMBR, bench-top, and manufacturing scales.  Further, process characterization was carried out on the microscale system using a DoE experimental strategy, and results generated were compared with 5L characterization data.  Predictive models for process variables and product quality attributes were obtained and compared between the characterization platforms.  This work will analyze and present attributes where the AMBR system matches bench top characterization performance. Additionally we will discuss gaps between the two systems with suggestions for improvement.

High throughput cell culture process characterization: Microscale bioreactor characterization for 15,000L cell culture process

247th National Meeting (2014)

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