FDA reviewers raised manufacturing and quality-control concerns that could make it prohibitively expensive to scale bespoke gene editing treatments for children with rare diseases, according to STAT+. The reporting focuses on the efforts behind treating “Baby KJ,” and describes a regulatory roadblock that would push the work toward industry-funded resources. The development matters for the gene editing field because it affects feasibility assumptions around highly customized nucleases, GMP processes, and batch consistency at scale. It also underscores that even when clinical concepts progress, regulatory expectations around manufacturing can become a gating factor. For innovators, the story reinforces the need to plan not only for biological efficacy, but also for an industrialization path that can satisfy FDA standards without constraining access to therapies.