Scientists reported a validated sterility assay capable of returning results within a single day for biopharmaceutical products, potentially disrupting long lead times in lot release. The approach uses accelerated detection chemistry and optimized sample processing to identify contaminating organisms faster than traditional culture‑based sterility testing. The publication outlines sensitivity, limits of detection, and comparative performance against pharmacopeial methods, noting reduced time to release without sacrificing specificity. Developers highlight implications for cell and gene therapies where batch shelf life and patient scheduling are time‑critical. Regulators and quality units will require bridging studies and formal validation to incorporate the assay into GMP release criteria and pharmacopoeial standards.