The U.S. Pharmacopeia (USP) released new standards aimed at viral vectors and plasmid DNA to improve quality and consistency for cell and gene therapy manufacturing. The guidance includes empty‑to‑full capsid ratio benchmarking and best practices for plasmid starting materials, developed with partners including NIST and NIIMBL. USP said the standards will support analytical comparability across labs and aid manufacturers and regulators as advanced therapies scale. The initiatives target persistent bottlenecks such as vector quantification variability, raw‑material heterogeneity and method transferability. Stakeholders indicated the standards should lower technical barriers, reduce batch‑to‑batch variability, and accelerate regulatory submissions by providing consensus measurement approaches for complex biologics.