GBI Biomanufacturing is preparing to launch its SmartScale GMP Solutions platform at BioProcess International East 2026, aiming to deliver GMP material for first-in-human studies faster. SmartScale is designed as a right-sized, small-scale cGMP pathway that targets early-stage biologics developers needing clinical-ready material without waiting for full-scale manufacturing timelines. GBI said SmartScale can produce GMP material in as little as eight months and integrates technologies from ATUM and Thomson Instrument to streamline cell line development, process scale-up, and manufacturing. The partnership includes ATUM’s Leap-In Transposase cell line approach and Thomson’s Optimum Growth flask to simplify transitions into GMP. The platform is also framed to align with the FDA’s Operation TrialBlazer initiative, positioning SmartScale as a practical response to development speed and resource constraints that often delay IND-enabling work.