Operational integration of the BioProfile FLEX2 analyzer into Sartorius AMBR250 workflows for upstream biologics development

Title : Operational integration of the BioProfile FLEX2 analyzer into Sartorius AMBR250 workflows for upstream biologics development

Abstract:

High-throughput microbioreactor platforms such as the Sartorius AMBR250 are widely used in upstream biologics process development, yet routine analytical workflows often rely on manual sampling and analysis. This presentation describes the integration of the BioProfile FLEX2 automated cell culture analyzer into daily AMBR250 operations within a regulated upstream development environment supporting Janssen, a Johnson and Johnson company.

Between December 2022 and August 2024, the FLEX2 analyzer was independently evaluated, qualified, validated, and operationally implemented to support routine AMBR250 analytical workflows. The platform enabled automated multi-parameter cell culture analysis, including metabolites, blood gases, electrolytes, osmolality, and cell health metrics, while aligning with existing upstream operational requirements. Four structured equivalency experiments were designed and executed to demonstrate analytical comparability between the FLEX2 and existing standard analyzers, enabling a controlled transition to automated analysis.

Automation of daily sampling and analysis resulted in an approximate 40 percent reduction in manual labor during AMBR operations, improving efficiency, consistency, and data reliability. To support scalability and adoption, 8 super users were trained at the Malvern, Pennsylvania site and 4 super users at the Spring House, Pennsylvania site, enabling independent operation and troubleshooting across multiple Janssen locations. Qualification and validation protocols were authored and executed for both the AMBR systems and the FLEX2 analyzer as part of advanced manufacturing technology initiatives.

The integrated workflow represented a significant operational advancement in upstream process development, delivering standardized and scalable analytical capabilities while maintaining data integrity and compliance expectations. This case study provides a practical example of how targeted automation can transform routine analytics in high-throughput biologics development environments.

Biography:

Sai Surya Raja Amogha Tenneti is a Scientist with over five years of hands-on experience in mammalian cell culture, protein large molecule bioprocessing, and automated bioreactor platforms. She has worked extensively in GMP-aligned environments and is recognized as an AMBR Super User with deep expertise in Sartorius ambr 15 and ambr 250 systems. Her work centers on upstream process development supporting monoclonal antibody and AAV production.

In her current role at Eurofins PSS at Janssen, Amogha independently designs, executes, and analyzes AMBR-based studies to optimize media performance, feeding strategies, and process parameters. She has led qualification and validation activities for AMBR systems and cell culture analyzers, authored and executed protocols, and contributed to automation initiatives that improved operational efficiency and data reliability. She also trains and mentors other scientists, strengthening team capability and technical expertise.

Amogha has a strong foundation in analytical and molecular techniques, including HPLC, LC-MS, ELISA, Western blotting, qPCR, and gas chromatography. Her background includes scale-down modeling, data analysis, troubleshooting, and cross-functional collaboration across upstream, analytical, and process development teams. She holds a Master of Science in Bioinnovation and a Bachelor of Science in Biochemistry from Temple University.