Experience.
Speed.
End-to-End cGMP Clinical and Commercial Manufacturing by a Leading US-based CDMO
As a full-service US-based CDMO, GBI offers scalable, phase-appropriate cGMP manufacturing services to support clinical and commercial biologics production. Our integrated platform spans cell culture, purification, manufacturing and aseptic fill and finish—serving innovators across therapeutic and diagnostic areas, including “naked” mAbs, bio-conjugates and other complex proteins.
We are proud to be among the most trusted CDMO companies in the US. We deliver regulatory-compliant manufacturing solutions for monoclonal antibodies (mAbs), vaccines, bio-conjugates, and more.
Contact Us Flexible Bioreactor Platforms for Batch, Fed-Batch & Perfusion Production
GBI supports diverse production modalities with multiple bioreactor platforms tailored to your process and scale requirements:
- Dakota Systems 200L and 500L stainless steel bioreactors with dedicated CIP and pure steam skids
- Cytiva XDR-200 200L, Sartorius Biostat STR Gen3 50L and 500L single-use bioreactors with perfusion capability (Repligen XCell ATF-2, ATF 6 and ATF10)
- Supporting equipment for cell culture development, including CO₂ incubators, 2D rockers, and 25L platforms from Cytiva and Sartorius, Solventum (3M), Millipore and Sartorius depth filter holders
- Purification suites with ÄKTA™ ready gradient and ÄKTA™ Process 10mm chromatography systems, plus TFF systems from Repligen, Sartorius, and Millipore
- 2,000L Sartorius single-use bioreactor for large-scale production
As a leading cGMP manufacturer, we ensure every project meets critical regulatory standards, with in-process testing, release testing, and comprehensive QA documentation. Reference standards are also available for regulatory submission readiness.
Integrated Upstream and Downstream Manufacturing Trains
GBI’s facility includes two independent upstream process trains with dedicated inoculation and bioreactor suites, along with shared pre-viral and post-viral downstream suites. This modular design provides maximum flexibility, scale-up capability, and control—ideal for projects in recombinant proteins, complex biologics and bio-conjugates manufacturing.
Expanding Capacity for Commercial cGMP Manufacturing
To meet the growing needs of our clients, GBI is expanding to support multi-product commercial manufacturing. Once complete, our facility will offer three independent process trains, each equipped for full-scale production with flexible volume scaling.
Each train includes:
- Sartorius Biostat STR Gen3 200L, 500L and 2000L, paired with Repligen ATF6 and ATF 10, Resolute SU chromatography, and Sartoflow TFF systems
- Cytiva XDR-200 bioreactor systems with ÄKTA™ ready gradient chromatography systems and Repligen KrosFlo TFF
- Dakota Systems 200L–500L stainless steel systems with ÄKTA™ Process and Sartorius Sartoflow TFF
This expansion further cements our status as a top CDMO US clients rely on for high-volume cGMP manufacturing and commercial readiness.
Vendor selection is important to product development, and as such we have selected GBI for manufacturing scale-up because of their track record in antibody conjugation, including radiopharmaceuticals.
Aggregate Removal Development and cGMP Manufacturing for a Conjugated Theranostic Product
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Whether launching a novel complex biologic, mAbs, or bio-conjugate scaling a biologic therapy, or transitioning to late-stage and commercial production, GBI offers the infrastructure, experience, and regulatory expertise to get you there faster.
Contact us today to learn how our cGMP clinical and commercial manufacturing solutions can support your program at every stage of development.
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