{
  "id": 8280424,
  "title": "GBI Biomanufacturing Set to Launch SmartScale GMP Solutions",
  "url": "https://urgent.news/2026/09/18/gbi-biomanufacturing-set-to-launch-smartscale-gmp-solutions",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-18T17:18:46.000Z",
  "source": {
    "name": "GEN Biotechnology",
    "slug": "gen-biotechnology",
    "url": "https://www.genengnews.com/topics/bioprocessing/gbi-biomanufacturing-set-to-launch-smartscale-gmp-solutions/"
  },
  "original_language": "en",
  "account": "CDMO GBI Biomanufacturing plans to unveil its SmartScale GMP Solutions platform at BioProcess International (BPI) East 2026. SmartScale is a rapid, small-scale cGMP manufacturing system created to enable early-stage biologics developers to produce GMP material for first-in-human studies more swiftly and effectively, according to Jesse McCool, PhD, CEO. The platform incorporates technologies from industry partners ATUM and Thomson Instrument to enhance cell line development, process scaleup, and manufacturing, McCool added. \"In the development of life-saving therapies, speed and simplicity can make a significant difference,\" continued McCool. \"Many early-stage drug developers require a more efficient route to acquiring the GMP material necessary to advance to clinical trials. SmartScale was designed to address this need by providing a suitable manufacturing approach that accelerates the journey to first-in-human studies.\" There is a growing demand among developers for methods that permit earlier clinical evaluation of promising candidates while simultaneously minimizing development risk, timelines, and capital expenditure. \"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 stated. \"Our objective is to assist customers in achieving the crucial milestone of generating human clinical data that supports future regulatory and commercial decisions.\" GBI highlighted that the platform is in line with the FDA's Operation TrialBlazer initiative, which aims to expedite the development of innovative therapies and modernize drug development pathways. GBI collaborated with ATUM to integrate ATUM's Leap-In Transposase® cell lines into the SmartScale platform, with the aim of maximizing drug substance yield at smaller scales. ATUM brings cell line expertise, having facilitated over 60 INDs across various therapeutic areas. Sam Ellis, CEO of Thomson Instrument, commented on the contribution of his company's Optimum Growth® Flask to the collaboration. \"The Optimum Growth® Flask was designed to simplify scaleup while maintaining high-performance cell culture conditions,\" said Ellis. \"As part of the SmartScale platform, our technology helps streamline the transition from research and development into GMP manufacturing.\"",
  "summary": "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. The post GBI Biomanufacturing Set to Launch SmartScale GMP Solutions appeared first on GEN - Genetic Engineering and Biotechnology News .",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}