- GBI Biomanufacturing will launch its SmartScale™ GMP Solutions platform at BioProcess International East 2026 in Boston, offering an accelerated small-scale cGMP manufacturing approach for early-stage biologics developers.
- The platform combines technologies from ATUM and Thomson Instrument Company to support cell line development, process scale-up and GMP manufacturing, with the company stating that GMP material can be delivered for first-in-human studies in as little as eight months.
GBI Biomanufacturing, a Florida-based contract development and manufacturing organization (CDMO), will launch its SmartScale™ GMP Solutions platform at BioProcess International (BPI) East 2026 in Boston next week. The company will showcase the platform and supporting data during the conference, where CEO Dr. Jesse McCool is scheduled to speak on the Innovation Stage at 5:15 p.m. on September 23.
SmartScale™ is an accelerated, small-scale cGMP manufacturing platform designed to help early-stage biologics developers generate GMP material for first-in-human studies. The platform combines technologies from ATUM and Thomson Instrument Company to streamline cell line development, process scale-up and manufacturing. GBI said the platform uses stable pool technology and can deliver GMP material for first-in-human studies in as little as eight months.
The company said biologic development through manufacturing and into human clinical trials can require investments of $5 million or more. SmartScale™ is intended to provide a right-sized manufacturing approach that can reduce development timelines, risk and capital requirements while enabling earlier clinical evaluation of drug candidates.
GBI has partnered with ATUM to integrate its Leap-In Transposase® cell lines into the SmartScale™ platform to maximize drug substance yield at smaller scales. ATUM said its cell line technology has supported more than 60 INDs across multiple therapeutic areas. Thomson Instrument Company is contributing its Optimum Growth® Flask technology, which is designed to simplify scale-up while maintaining cell culture conditions.
GBI said SmartScale™ aligns with the FDA’s Operation TrialBlazer initiative, which seeks to accelerate innovative therapy development and modernize drug development pathways. Through the platform, GBI, ATUM and Thomson Instrument Company aim to combine stable pool technology, streamlined bioprocessing workflows and small-scale GMP manufacturing to help developers generate clinical material and human data earlier in the development process.
