Experience.
SmartScale™
SmartScale™ GMP Platform is Blazing the Trail to First-in-Human
GBI Biomanufacturing’s SmartScale™ GMP platform is a purpose-built, gene-to-GMP vial manufacturing service for biotech sponsors pursuing expedited
first-in-human (FIH) biologics programs.
Leveraging the FDA’s revised regulatory flexibilities and clarifications for FIH Phase 1 Investigational New Drugs (INDs) (June 2026), SmartScale reduces the cost of FIH drug product production by 4X. The platform delivers drug product in 8 months for standard biologics.
What SmartScale Integrates
- Deferred cloning Chemistry, Manufacturing, and Controls (CMC) strategy for Phase I FIH material
- Novel single-use manufacturing technology platform with proven scalability to commercial
- A CMC and regulatory strategy built directly around FDA’s own CMC flexibilities
- Support for monoclonal antibodies; bispecific antibodies are under evaluation with the platform
Right-Sized Partner for Emerging Biologics
- Unlike traditional blockbuster-focused contract development and manufacturing organizations (CDMOs), GBI is designed around the needs of innovative biotech companies
- An early-phase FIH study typically needs approximately 100 mg of drug substance
- Most CDMO manufacturing suites are built around commercial-scale campaigns closer to 10 kg per run
- That mismatch drives up cost, timeline, and manufacturing complexity for programs that do not need commercial-scale infrastructure yet
- SmartScale is scaled and priced for what an early-phase program actually requires, contributing to sustainability from capital and material generation perspectives.
New Tailwinds with Operation TrialBlazer + SmartScale
- HHS’s 2026 Operation TrialBlazer roadmap and FDA’s associated Expedited-IND Acceleration Pilot signal an agency-wide push toward faster, risk-based pathways to first-in-human data¹
- SmartScale’s CMC workflow is built to operate inside the CMC flexibilities that the FDA has already published for Phase 1 INDs under 21 CFR 312.23
- Speed and affordability of SmartScale manufacturing unlocks this new paradigm shift in biologics development
Right-Sized Partner for Emerging Biologics
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8 Months
Gene-to-GMP vial
(as fast as 5 for radioimmunoconjugate programs) -
50-100 grams
Manufacturing scale matched to what an FIH study needs
-
4X
Estimated reduction in drug development costs from gene to GMP for FIH
-
21 CFR 312.23
Built on FDA’s existing Phase 1 IND CMC flexibilities
Full-Service SmartScale™ GMP Manufacturing
Our technical team engineers each SmartScale program uniquely around the material quantity required, timeline, and regulatory posture an expedited first-in-human study requires. SmartScale is built on three integrated components:
Component
Stable Pool-Based Cell Line Development
Right-Scale, Single-Use Upstream Manufacturing
Expedited CMC Strategy
What It Is
ATUM’s Leap-In® Transposase platform generates highly uniform, stable cell pools in 5–6 weeks — no single-cell cloning required.
GMP manufacturing with stable pools utilizing Thomson Instrument’s OptimumGrowth® 7 L single-use flasks or 50 L, 200 L or 500 L bioreactors.
A CMC and regulatory strategy built around Operation TrialBlazer and FDA’s Phase 1 IND flexibilities, backed by a dedicated regulatory team for every SmartScale program.
Why It Matters to Your Program
Cuts cell line development from ~22 weeks to ~8 weeks and reduces cost.
Matches manufacturing scale and cost to what an early-phase study actually needs — not a commercial campaign, fostering sustainability from budgetary and resource perspectives.
Removes unnecessary burdens to get GMP material for early-phase IND applications.
FDA's Expedited Path for Early-Phase Biologics
SmartScale’s regulatory strategy is grounded directly in FDA’s published Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs.2 The table below maps standard commercial-stage expectations against the flexibilities FDA extends at the Phase 1 IND stage — and where SmartScale is built to operate.
Gene to
Stable Pool
Testing checkpoint for identity, mycoplasma & sterility; pool used directly in GMP after testing
Gene to
Tox Material Shipped
Material released and shipped for IND-enabling toxicology studies
Gene to GMP Drug Product
+ 1-Month Stability
1-month stability is FDA’s minimum data requirement for an IND submission
First In Human Material Cost
Total program cost from gene to FIH material
Stable Pools–A Decade of Peer-Reviewed Comparability Data
Deferred cloning is not a new or unproven concept. It’s supported by a decade of published, peer-reviewed comparability work from outside GBI, most notably Boehringer Ingelheim’s 2022 publication on transposon-mediated stable pools (Journal of Biotechnology 349 (2022) 53–64). The proof points:
- GMP manufacturing directly from stable pools at scales up to 8 × 2,000 L
- Clinical material generated in under 3 months from transposition
- Phase 1 enablement in approximately 6 months from transfection
- Process and product-quality comparability demonstrated at scale-up (2 × 80 L and 4 × 12,000 L clone-derived material shown comparable to 8 × 2,000 L pool-derived material)
- A commercial cell line was subsequently established from the same parental pool — pools don’t foreclose a commercial-scale path
- Sponsors retain the option to run conventional single-cell cloning and master cell bank generation in parallel, from the same frozen RCB, without repeating any upstream work
The SmartScale Technology Stack
Strategic collaboration with industry-leading bioprocessing solutions providers has enabled the creation of the SmartScale gene-to-GMP vial platform.
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ATUM
ATUM’s Leap-In® Transposase platform creates uniform cell populations where each integration maintains structural integrity, resulting in consistent expression across the pool.
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Thomson
Thomson Instrument Company’s OptimumGrowth® 7 L single-use flask platform, engineered to outperform stirred-tank bioreactors at comparable volumes.
Partner with a CDMO Blazing the Trail to First-in-Human
Whether you’re advancing a monoclonal or bispecific antibody toward first-in-human studies, GBI’s SmartScale™ GMP platform delivers the technical expertise, right-sized manufacturing capacity, and phase-appropriate regulatory strategy needed to accelerate your path to the clinic in months, not years.
Get StartedReferences
- Operation Trialblazer HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development
- Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs
