Optimised rAAV vector systems and production platforms for scalable viral vector manufacture
Recombinant adeno-associated viral vectors (rAAV) have emerged as a powerful tool for in vivo gene delivery owing to their unique characteristics, including a high safety profile and ability to drive long-term gene expression in humans. However, the ability to produce large quantities of functional rAAV particles in a scalable manufacturing system remains challenging. OXGENE has developed an optimised packaging plasmid system based on the reconfiguration of Rep-Cap coding sequences to increase the yield and quality of rAAV vectors produced. A clonal cGMP-compliant HEK293 suspension cell line has also been identified as the optimal rAAV production platform, enabling high-titre rAAV production for multiple serotypes and allowing rapid transfer to cGMP manufacture. Here, we provide an overview of the current rAAV production platform at OXGENE, focusing on the individual upstream and downstream unit operations, as well as analytical assay development for more accurate and complete characterisation of rAAV vectors.
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