GBI Biomanufacturing plans to launch SmartScale GMP Solutions, an accelerated small-scale cGMP manufacturing platform meant to supply GMP material for first-in-human studies faster. The platform is designed for early-stage biologics developers seeking to generate human-ready lots while reducing timelines, development risk, and capital needs. GBI says SmartScale can deliver GMP material in as little as eight months and aligns with the FDA’s Operation TrialBlazer initiative to modernize development pathways. The platform combines capabilities from ATUM and Thomson Instrument, streamlining cell line development, process scale-up, and manufacturing. The program includes integration of ATUM’s Leap-In Transposase cell lines, which the companies said enable over 60 INDs across therapeutic areas. Thomson Instrument contributes an Optimum Growth Flask intended to simplify scale-up while maintaining high-performance culture conditions. For CDMO customers, the value proposition is straightforward: reduce the gap between IND-enabling research and GMP manufacturing execution, while keeping process control and documentation consistent across smaller production footprints.