The Importance Of AAV Process Comparability Throughout Development

By Markus Hörer, Chief Scientific Officer

Developing scalable and compliant viral vector production platforms for gene therapies and vaccines poses unique challenges, especially for smaller companies navigating rapid timelines and funding constraints. Initial reliance on non-scalable platforms often necessitates changes during development, which can jeopardize product quality and invalidate early clinical data. As production scales up, ensuring comparability of efficacy, safety, and quality becomes increasingly complex, particularly during late-stage development where regulatory scrutiny intensifies.

Switching platforms or scaling processes demands robust comparability data, and regulators may require clinical bridging studies to confirm product consistency, leading to costly delays. To avoid these risks, developers should define the target product profile and select scalable production platforms early, incorporating regulatory feedback into their strategy.

Ascend offers expertise in optimizing viral vector production platforms to mitigate risks, meet regulatory expectations, and accelerate development timelines, ensuring a seamless transition from preclinical to commercial production and delivering transformative therapies to patients efficiently.