Plantation, Fla. — GBI Biomanufacturing will launch its new SmartScale GMP Solutions platform at BioProcess International East 2026 in Boston, offering early-stage biologics developers an accelerated path to producing GMP material for first-in-human studies.
The Florida-based contract development and manufacturing organization said the platform was developed in partnership with ATUM and Thomson Instrument Company and is designed to streamline cell line development, process scale-up and manufacturing.
GBI CEO Dr. Jesse McCool is scheduled to present SmartScale at the conference on Sept. 23.
“When developing life-saving therapies, speed and simplicity can make a significant difference,” McCool said. “Many early-stage drug developers need a more efficient path to obtaining the GMP material required to reach the clinic.”
GBI said SmartScale is a stable pool-based manufacturing platform that can deliver GMP material for first-in-human studies in as little as eight months.
The company said biologic development through entry into human clinical trials can require investments of $5 million or more, creating demand for manufacturing approaches that can reduce timelines and capital requirements while allowing developers to evaluate candidates earlier.
“Our goal is to help customers reach the critical milestone of generating human clinical data that supports future regulatory and commercial decisions,” McCool said.
The platform incorporates ATUM’s Leap-In Transposase cell line technology, which is intended to improve drug substance yields at smaller manufacturing scales. ATUM said its cell line technologies have supported more than 60 Investigational New Drug applications 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.”
SmartScale also incorporates Thomson Instrument Company’s Optimum Growth Flask technology to support cell culture scale-up from research and development into GMP manufacturing.
“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.
GBI said the platform is designed to support faster generation of clinical material through stable pool technology, streamlined bioprocessing workflows and small-scale GMP manufacturing.
The company said the approach is also aligned with efforts to modernize drug development and move promising therapies into clinical evaluation more efficiently.
