GBI
GBI Biomanufacturing is a full-service biopharmaceutical CDMO based in Florida, dedicated to eliminating manufacturing risk for companies developing complex biologic therapeutics. They offer extensive development services, state-of-the-art manufacturing equipment, and project support, aiming to be a comprehensive biologics partner. Their mission is to provide a single-source solution for biologics development, manufacturing, and support, ensuring projects are completed on time and within budget. GBI specializes in bioconjugation, biologics process development, and manufacturing, with a focus on innovative therapies such as radiopharmaceuticals and biosimilars. They leverage advanced technologies, rigorous regulatory compliance, and a proven track record of scale-up from small-scale experiments to commercial production.
Industries
Nr. of Employees
medium (51-250)
GBI
1850 N.W. 69th Avenue, Plantation, FL 33313, USA
Services
Small- to pilot-scale process development for mammalian cell culture, including bioreactor optimization to support GMP runs.
Application of designed experiments at small bioreactor scale to identify optimal clones and process parameters, modulate glycosylation profiles, and generate development material for downstream optimization and scale-up.
Creation and testing of research, master and working cell banks under cGMP with cryogenic storage and documented release testing.
Process development and scale-up for protein purification including chromatography, viral clearance steps, and TFF operations.
End-to-end GMP manufacturing of drug substance and drug product across multiple bioreactor scales and platforms with QA/QC oversight.
Development and GMP manufacture of antibody–drug, antibody–oligonucleotide, and antibody–chelator conjugates with control of linker chemistry and payload ratio.
Small- to pilot-scale process development for mammalian cell culture, including bioreactor optimization to support GMP runs.
Application of designed experiments at small bioreactor scale to identify optimal clones and process parameters, modulate glycosylation profiles, and generate development material for downstream optimization and scale-up.
Creation and testing of research, master and working cell banks under cGMP with cryogenic storage and documented release testing.
Process development and scale-up for protein purification including chromatography, viral clearance steps, and TFF operations.
End-to-end GMP manufacturing of drug substance and drug product across multiple bioreactor scales and platforms with QA/QC oversight.
Development and GMP manufacture of antibody–drug, antibody–oligonucleotide, and antibody–chelator conjugates with control of linker chemistry and payload ratio.
Expertise Areas
- Upstream cell culture and cell line development
- Design of Experiments (DoE) for process optimization and clone selection
- Downstream purification and chromatography
- cGMP clinical and commercial biologics manufacturing
Key Technologies
- Single-use bioreactor platforms
- Perfusion manufacturing with ATF
- Protein A and multimodal chromatography
- Tangential flow filtration (TFF/UFDF)
News & Updates
Press release about collaboration to manufacture therapeutic antibody.
Announcement of a new contract in radiopharmaceutical manufacturing.
An article discussing strategies for efficient biopharmaceutical production.
Insights into effective stakeholder communication in biotech projects.
Over 20 years of experience in biologics manufacturing
GBI has over two decades of expertise in biologics development and manufacturing.
Developed and manufactured a wide range of antibody conjugates including radiopharmaceuticals
GBI has a proven track record in antibody conjugate development, including radiolabeled antibodies.
Press release about collaboration to manufacture therapeutic antibody.
Announcement of a new contract in radiopharmaceutical manufacturing.
An article discussing strategies for efficient biopharmaceutical production.
Insights into effective stakeholder communication in biotech projects.
Over 20 years of experience in biologics manufacturing
GBI has over two decades of expertise in biologics development and manufacturing.
Developed and manufactured a wide range of antibody conjugates including radiopharmaceuticals
GBI has a proven track record in antibody conjugate development, including radiolabeled antibodies.