GBI Biomanufacturing to Launch SmartScale™ GMP Solutions at BioProcess International East 2026

Accelerated manufacturing platform, developed in partnership with ATUM and Thomson Instrument Company, helps drug developers reach first-in-human studies faster

PLANTATION, Fla., Sept. 17, 2026 /PRNewswire/ -- GBI Biomanufacturing, a Florida-based contract development and manufacturing organization (CDMO), will announce the launch of its new SmartScale™ GMP Solutions platform at BioProcess International (BPI) East 2026 in Boston next week. The company will showcase the platform and data during the conference, where Dr. Jesse McCool, Chief Executive Officer, is scheduled to speak at 5:15 p.m., Sept. 23, on the Innovation Stage.

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. The platform combines technologies from industry partners ATUM and Thomson Instrument Company to streamline cell line development, process scale-up, and manufacturing.

GBI Biomanufacturing to Launch SmartScale™ at BPI East in Boston

"When developing life-saving therapies, speed and simplicity can make a significant difference," said Dr. Jesse McCool, CEO of GBI Biomanufacturing. "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."

According to McCool, bringing a biologic therapy from development through manufacturing and into human clinical trials can require investments of $5 million or more. As a result, 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.

The introduction of SmartScale™ comes as regulators and industry stakeholders increasingly seek ways to reduce development timelines without compromising quality, safety, or scientific rigor. Through Operation TrialBlazer, the FDA has highlighted opportunities to modernize drug development by encouraging innovative manufacturing strategies and regulatory approaches that can help promising therapies advance more efficiently toward clinical evaluation.

By leveraging stable pool technology, streamlined process development, and right-sized GMP manufacturing, SmartScale™ is designed to support these objectives, enabling developers to generate clinical material more efficiently while gathering critical human data earlier in the development process.

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

"The culmination of 20+ years of ATUM R&D is embedded in every cell line we deliver," said Claes Gustafsson, ATUM co-founder. "Making complex biologics doesn't have to be complex, and we're thrilled GBI selected ATUM as a cornerstone for SmartScale."

"The Optimum Growth ® Flask was designed to simplify scale-up while maintaining high-performance cell culture conditions," said Sam Ellis, CEO of Thomson Instrument Company. "As part of the SmartScale™ platform, our technology helps streamline the transition from research and development into GMP manufacturing."

Amid increasing global competition in biopharmaceutical innovation, GBI Biomanufacturing, ATUM, and Thomson Instrument Company have combined their technologies to create an integrated solution designed specifically for first-in-human development programs. By leveraging stable pool technology, streamlined bioprocessing workflows, and accelerated GMP manufacturing capabilities, the partners aim to help drug developers reduce timelines, improve operational efficiency, and advance promising therapies to the clinic more quickly.

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PR Counsel for GBI Biomanufacturing

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SOURCE GBI Biomanufacturing