AAV9 Process Robustness Evaluation in Cloud-native 250mL Bioreactors

This poster interview features Jean-Marc Guedon, director application technologies, Culture Biosciences, from Biotech Week Boston 2024.

Widely used adeno-associated virus (AAV) production systems involve transfection of plasmids into host cells to produce a target viral vector. Although AAV production processes can be independently developed by individual labs or companies, they are generally difficult to standardize, have limited robustness, and often lead to manufacturing and supply chain challenges. Utilizing validated off-the-shelf production systems allows researchers and therapy developers to incorporate platform processes that standardize process development, helping save time and cost. We evaluated AAV9 production using the Gibco™ AAV-MAX Helper-Free AAV Production System in 250mL cloud-native bioreactors. Our experiments investigated process acceptable ranges for dissolved oxygen (DO), agitation, pH at transfection, and viable cell density (VCD) while maintaining other process parameters at manufacturer-recommended levels. Analysis of both viral genome titer and percent full capsids demonstrate adjustment of these parameters within the range tested results in titers comparable to the control process. This confirms that the production system is robust in laboratory scale bioreactors. All process parameters were investigated in parallel in highly characterized 250mL bioreactor systems that enable straightforward scaling of processes to manufacturing scale. Our fleet of 250mL and 5L bioreactors can be leveraged to allow expedient and large-scale investigations to be completed while freeing up internal viral vector production capacity and allowing for real-time data access.

View the full poster here.