GBI Biomanufacturing Launches SmartScale™ GMP Solutions for Accelerated Biologics Development
News related to:GBI Biomanufacturing · 1 min read
GBI Biomanufacturing is set to launch a new accelerated manufacturing platform, SmartScale™ GMP Solutions, at the BioProcess International East 2026 conference in Boston. The platform, developed in partnership with ATUM and Thomson Instrument Company, aims to streamline the process of generating Good Manufacturing Practice (GMP) material for first-in-human studies.
Dr. Jesse McCool, CEO of GBI Biomanufacturing, highlighted the importance of speed and simplicity in drug development.
SmartScale™ combines technologies from ATUM and Thomson Instrument Company to streamline cell line development, process scale-up, and manufacturing. The platform is designed to support the FDA's Operation TrialBlazer initiative, which seeks to accelerate the development of innovative therapies and modernize drug development pathways.
According to McCool, the platform can deliver GMP material for first-in-human studies in as little as eight months.
The introduction of SmartScale™ comes as regulators and industry stakeholders increasingly seek ways to reduce development timelines without compromising quality, safety, or scientific rigor. By leveraging stable pool technology, streamlined bioprocessing workflows, and accelerated GMP manufacturing, the platform aims to support these objectives.
ATUM has partnered with GBI Biomanufacturing to integrate ATUM's Leap-In Transposase® cell lines into the SmartScale™ platform.
Thomson Instrument Company has also contributed to the platform by designing the Optimum Growth® Flask, which simplifies scale-up while maintaining high-performance cell culture conditions.
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, the partners aim to help drug developers reduce timelines, improve operational efficiency, and advance promising therapies to the clinic more quickly.
The launch of SmartScale™ marks a significant step in the biopharmaceutical industry, offering a more efficient and accelerated path to first-in-human studies. The platform is expected to play a crucial role in reducing development risks, timelines, and capital requirements for early-stage biologics developers.