Construct Viability: A Hidden Challenge In Viral Vector Manufacturing

Construct viability is increasingly recognized as a hidden but critical factor in viral vector manufacturing, often revealing its impact only when programs near IND-enabling stages. Teams may spend years optimizing the biology of an AAV or LVV therapy, only to encounter manufacturability obstacles—such as poor yields, unfavorable backbone elements, or regulatory‑sensitive sequences—when scaling up. These issues can delay development, increase costs, or require late‑stage redesigns that set programs back months.

Growing pressure for speed‑to‑clinic and funding milestones often pushes manufacturability considerations aside, creating blind spots that only surface when timelines and budgets are most vulnerable. A rapid, low‑cost “construct viability health check” offers a practical way to identify red flags early, from promoter and codon optimization concerns to discouraged resistance markers or unstable regulatory elements. Addressing these issues upfront strengthens vector performance, reduces CMC risks, and positions programs for a smoother, more predictable path toward clinical readiness.