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GBI Biomanufacturing Set to Launch SmartScale GMP Solutions

GBI Biomanufacturing Set to Launch SmartScale GMP Solutions

The GBI platform combines technologies from industry partners ATUM and Thomson Instrument to streamline cell line development, process scaleup, and manufacturing. [Sergunt/Getty Images]
The GBI platform combines technologies from industry partners ATUM and Thomson Instrument to streamline cell line development, process scaleup, and manufacturing. [Sergunt/Getty Images]

CDMO GBI Biomanufacturing will announce the launch of its new SmartScale™ GMP Solutions platform at BioProcess International (BPI) East 2026. SmartScale is an accelerated, small-scale cGMP manufacturing platform designed to help early-stage biologics developers generate GMP material for first-in-human studies faster and more efficiently, according to Jesse McCool, PhD, CEO.

The platform combines technologies from industry partners ATUM and Thomson Instrument to streamline cell line development, process scaleup, and manufacturing, he added.

“When developing life-saving therapies, speed and simplicity can make a significant difference,” continued McCool. “Many early-stage drug developers need a more efficient path to obtaining the GMP material required to reach the clinic. SmartScale was designed to help close that gap by providing a right-sized manufacturing approach that accelerates the journey to first-in-human studies.”

Developers increasingly seek approaches that enable earlier clinical evaluation of promising candidates while reducing development risk, timelines, and capital requirements.

“SmartScale is a stable pool-based manufacturing platform that can deliver GMP material for first-in-human studies in as little as eight months,” McCool said. “Our goal is to help customers reach the critical milestone of generating human clinical data that supports future regulatory and commercial decisions.”

GBI noted that the platform aligns with the FDA’s Operation TrialBlazer initiative, which seeks to accelerate the development of innovative therapies and modernize drug development pathways.

GBI partnered with ATUM to integrate ATUM’s Leap-In Transposase® cell lines into its SmartScale platform, aimed at maximizing drug substance yield at smaller scales. ATUM brings cell line expertise, having enabled over 60 INDs across multiple therapeutic areas.

“The Optimum Growth® Flask was designed to simplify scaleup while maintaining high-performance cell culture conditions,” said Sam Ellis, CEO of Thomson Instrument, about his company’s other contribution to the collaboration. “As part of the SmartScale platform, our technology helps streamline the transition from research and development into GMP manufacturing.”