Gene Therapy is transforming modern medicine, offering hope for conditions once considered untreatable. However, as this complex field advances, the demands of patient safety and regulatory compliance mean that non-functional or surrogate potency testing is no longer enough—regulators now expect assays that reflect the therapy’s true mechanism of action (MoA).
In this article, Alan Griffith, Head of Operations at VectorBuilder, shares why MoA-linked potency assays are critical throughout the development lifecycle—from early pipeline decisions to market authorization. It has become clear that an effective, reliable Gene Therapy needs a robust understanding of MoA from the very beginning of the product lifecycle to help developers stress-test therapies, improve reproducibility, and accelerate timelines.
Drawing on over 15 years of experience, Griffith also emphasizes that selecting the right scientific partners can be just as important to success as the therapy itself and how a dedicated assay specialist like Svar Life Science can provide in-depth technical knowledge and scientific collaboration, which can make the difference between success and costly delays.