Andelyn Biosciences said it is manufacturing Fayuvi (rebisufligene etisparvovec-hopf) for commercial supply, following the FDA approval of the Sanfilippo syndrome type A gene therapy developed by Ultragenyx. Andelyn described the output as the first commercial manufacturing tied to its AAV Curator platform approach, with production also occurring at Ultragenyx’s facility in Bedford, Massachusetts. The milestone matters for the gene therapy supply chain, where platformized process development and analytics can reduce variability and help ensure consistent product quality at scale. For rare disease markets, the ability to expand manufacturing capacity without quality regression is a key gating factor for treatment access. Andelyn framed the AAV Curator platform as configurable and data-informed, integrating process knowledge, modular manufacturing strategies, and fit-for-purpose analytics across development through launch.