A rapid, multi‑partner effort produced a personalized CRISPR gene therapy for Baby KJ’s urea cycle disorder, converting academic discovery to a clinical candidate within months. The coordinated program spanned guide‑RNA design, mRNA synthesis, lipid‑nanoparticle formulation and GMP manufacturing across multiple commercial and academic partners, showcasing a modular pathway for individualized medicines. The report highlights operational lessons—cross‑company coordination, rapid analytical bridging and regulatory engagement—that could inform future n=1 therapeutics for rare, life‑threatening conditions. Authors noted manufacturing scalability and regulatory pathways remain key constraints for broader adoption of personalized gene‑editing interventions.