Gene Therapy CDMOs Play Critical Role In Enabling AAV Process Improvement & Standardization

By Wes McConnell, CFO

The rise of gene and gene-modified cell therapies has solidified the role of adeno-associated viruses (AAVs) as a preferred in vivo gene therapy vector due to their safety and versatility. With seven FDA- or EMA-approved AAV therapies and over 300 candidates in development, these therapies promise durable, potentially curative outcomes. However, scaling AAV manufacturing to meet demand while ensuring high yield, quality, and cost-efficiency remains a significant challenge.

Emerging biotech companies, the primary drivers of AAV innovation, often lack the resources to develop scalable, GMP-compliant processes in-house. Outsourcing to CDMOs like Ascend offers access to cutting-edge platform technologies, streamlined processes, and regulatory expertise, enabling developers to overcome barriers in production and compliance. As the global AAV vector manufacturing market grows, CDMOs with proven experience provide essential support in accelerating development timelines, reducing costs, and guiding products through complex regulatory pathways to commercialization. Collaborate with Ascend to realize the full potential of AAV gene therapies.