Trenchant Biosystems released prototype data for its AutoCell automated cell‑and‑gene therapy (CGT) manufacturing platform, reporting up to seven‑fold increases in gene‑modified cell yield and projected cost reductions of as much as 80% versus current approaches. Company validation runs showed faster vein‑to‑vein timelines and external testing partners verified key unit operations. Concurrently, the FDA’s Center for Biologics Evaluation and Research signaled regulatory flexibility by easing certain chemical, manufacturing and control (CMC) requirements for CGTs—guidance intended to expedite development while maintaining safety standards. The agency framed the move as a modernization step to reflect growing CGT experience. Taken together, advanced automation prototypes and regulatory adjustments aim to reduce manufacturing complexity, cut timelines, and lower cost barriers that have limited CGT scalability and repeat dosing strategies.