CDMO GBI Biomanufacturing said it will launch SmartScale GMP Solutions, an accelerated small-scale cGMP platform designed to deliver material for first-in-human studies faster. The company said SmartScale will combine technologies from ATUM and Thomson Instrument to streamline cell line development, process scaleup, and manufacturing. GBI characterized the platform as enabling GMP material in as little as eight months, targeting a persistent bottleneck for early-stage biologics developers who must reach clinical dosing while managing capital and timeline risk. The company also aligned SmartScale with the FDA’s Operation TrialBlazer initiative, which aims to modernize and accelerate clinical development pathways. As part of the collaboration, GBI will integrate ATUM’s Leap-In transposase cell lines and Thomson’s Optimum Growth flask approach, aiming to maintain yield and process performance as manufacturing scales down to an earlier, “right-sized” format.
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