Development and scale-up of a transient transfection rAAV process to a next-generation, single-use bioreactor system

The scale-up of transient transfection processes for recombinant AAV poses challenges in maintaining consistent productivity and product quality across volumes. This article presents case studies demonstrating the use of a HEK293-derived transient cell line to achieve reproducible rAAV9 titers (2–4 × 10¹¹ vg/mL) with 23–33% full capsids, while demonstrating low encapsidated host-cell DNA of 18 ng/10¹⁴vg. Results confirm reproducibility from 15 mL bench-scale runs through 200 L single-use bioreactors, supported by defined strategies for agitation, pH, and dissolved oxygen control.

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