GBI Biomanufacturing Unveils SmartScale Platform to Accelerate Clinical Trials
With drug development costs often exceeding $5 million before human trials, Florida-based GBI Biomanufacturing is launching a new cGMP platform at BioProcess International East 2026. The system aims to shrink the timeline for producing clinical-grade biologics to just eight months, addressing a critical bottleneck for early-stage developers.
The SmartScale platform integrates specialized technologies from ATUM and Thomson Instrument Company to streamline cell line development and process scale-up. By utilizing stable pool-based manufacturing, the company seeks to provide a right-sized approach that lowers capital requirements and development risks. GBI CEO Dr. Jesse McCool will detail the platform's capabilities during the BPI East conference in Boston on September 23.
This launch aligns with the FDA’s Operation TrialBlazer initiative, which encourages modernized manufacturing strategies to speed up the delivery of innovative therapies. GBI incorporates ATUM’s Leap-In Transposase cell lines—which have supported over 60 IND filings—alongside Thomson Instrument Company’s Optimum Growth Flasks to maintain high-performance culture conditions during the transition from research to GMP production. By combining these workflows, the partners intend to help developers reach the milestone of human clinical data significantly faster than traditional methods allow.
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