Enhanced AAV2 Production Process Control and Insight through Integration of Numera® Automated Sampling at Catapult

Written by: Joe Harvey, Omaymah Belhaj-Fahsi, John Churchwell, Isobelle Evie, Vera Karels, Dragoș-Horea Mărginean, Rolando Matos, Chris O’Grady, Mohsen Shaeri, Caitlin Thompson and Rhys Macown                                        Published at Securecell website by: Mohi Ahmadinia

Current AAV process monitoring relies on sporadic manual sampling and analysis, with atline analytics usually operating independently of bioreactor control systems, which prevents real-time process control.

The Securecell Numera® system facilitates fluidic integration of atline analytics with bioreactor systems, enabling automated sample scheduling and allowing atline measurements to influence bioreactor operations through the integrated Lucullus® software directly. This system was utilized in a transient AAV2 production process using an 8-STR DASbox® system for both offline and automated at-line monitoring. The results showed that manual and automated sampling provided comparable measurements for cell viability, density, metabolite concentrations, transfection efficiency, and AAV2 titers. This highlights the system's potential as a powerful tool to enhance sampling frequency, process understanding, and data-driven process control strategies.

Image reference: Attached published poster at Catapult (Cell and gene therapy)Image reference: Attached poster - published at Catapult (Cell and gene therapy)

This work was conducted at the newly established Cell and Gene Therapy Catapult PAT Laboratory, an advanced bioprocessing facility dedicated to fully automated sampling and real-time sample analysis. The laboratory is equipped with cutting-edge in-line and atline monitoring tools, complemented by multi-omics capabilities, enabling collaborators to identify and assess critical process parameters in real-time. Additionally, state-of-the-art automation and digitalization within the facility support swift and precise process control.

The Numera® autosampling system was employed to monitor an AAV2 production process, demonstrating comparable measurements for cell counting, metabolite profiling, and AAV2 quantification between manually and automatically collected samples. The system has since been integrated with the Lucullus® data management and capture platform, enabling centralized monitoring and control of AAV2 production experiments.

Numera and analytical overview -Catapult
Image reference: Attached poster - published at Catapult (Cell and gene therapy)

 

Download a published poster from Catapult (Cell and gene therapy) in PDF

 

Reference:
Attached poster - published at Catapult (Cell and gene therapy)

Mohi Ahmadinia

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