Scaling AAV Production: From 250 mL to 200 L
Scaling adeno-associated virus (AAV) production from laboratory to manufacturing volumes remains a major challenge for gene therapy developers, particularly when trying to preserve productivity, quality, and cost efficiency.
In this application note, Ascend Advanced Therapies and Sartorius present a collaborative approach to scalable upstream AAV manufacturing, demonstrating consistent vector production from 250 mL to 200 L. Using HEK293 cells, optimized media, and a streamlined transfection strategy, the process delivers stable performance across laboratory, pilot, and production-scale bioreactors. Key critical quality attributes—including viral genome and capsid titers, DNA impurity levels, full capsid ratios, and potency—were maintained at each scale. The results highlight a robust and flexible path to accelerate development timelines and transition efficiently from process development to GMP‑relevant manufacturing volumes.
Key takeaways
Demonstrate consistent AAV productivity and quality during scale-up from 250 mL to 200 L using a standardized upstream process.
Maintain critical quality attributes—including titers, impurity levels, full capsid ratios, and potency—across laboratory and manufacturing scales.
Enable flexible scale-up using both two‑plasmid and conventional triple‑plasmid transfection strategies without compromising performance.
