The U.S. Pharmacopeia (USP) launched new standards aimed at improving quality and consistency in viral‑vector production for cell and gene therapies, including guidance for plasmid DNA starting materials and empty‑full ratio measurement for AAV. USP developed the standards with NIST and NIIMBL and plans final chapters for AAV and plasmid best practices in 2026, with future work on lentivirus and CAR‑T manufacturing. Stakeholders said the move addresses a key bottleneck in advanced‑therapy manufacturing — assay variability and raw‑material heterogeneity — and could ease regulatory reviews and tech transfer. The standards are expected to support manufacturers and regulators as the field scales clinical and commercial production.