(8d) Using a High Throughput Cell Culture Workflow for Process Development and Process Characterization for Therapeutic Proteins

Application of high throughput technologies for biologics allows new molecules to transition from bench-scale to at-scale manufacturing and to the clinic at a faster rate. We have established a high throughput workflow for upstream cell culture bioreactor experiments, sample preparation, sample submission, tracking and analytical testing to increase efficiency across all process development and process characterization projects.

This workflow begins with the use of ambr15â„¢ and ambr250â„¢ (Sartorius) bioreactor systems. Traditionally, bench-scale bioreactor systems (2-L to 5-L) were used for process development and process characterization, but these bioreactors have a longer turnaround time and require more resources for preparation and study execution. Use of disposable ambrâ„¢ bioreactor systems enable scientists to perform 24 to 48 bioreactor runs in parallel, with significantly lower resource need. Sample preparation and sample handling with high throughput bioreactor systems can be challenging. We have implemented an approach for sample preparation using a sample numbering system, TubeWriter, plate centrifuges, Opentron liquid handler and sample tracking using barcodes. This workflow and procedures have been harmonized across all groups in the department.

We will present our approach for establishing this workflow, resource and throughput comparison between traditional bioreactor system and ambrâ„¢ systems, efficiency gain in sample preparation and sample handling using the high throughput technologies. We consider high throughput as a means for continuous improvement to meet our goal of Gene to GMP in 9 months.