GBI Biomanufacturing

Overview

GBI Biomanufacturing is a full-service contract development and manufacturing organization (CDMO) based in Plantation, Florida, specializing in complex biologic therapeutics. The company provides an integrated suite of development and manufacturing services under its Single-Source Solution™ platform, designed to move projects from strategy through commercial production.

Development & Manufacturing Services

Upstream & Downstream Processing

• Upstream processing cell culture development with stirred-tank batch and fed-batch bioreactors (250 mL to 40 L in process development; 200 L, 500 L, and 2,000 L in cGMP core)
• Perfusion bioreactors (Fibra-Cel disk immobilized bed systems: XCell™ ATF 2 in development, XCell™ ATF 6 in cGMP)
• DSP purification development with multiple ÄKTA™ systems for downstream processing
• cGMP cell banking services

Specialized Manufacturing

• Bioconjugation services with Mettler Toledo Advanced Synthesis system for controlled, scalable processes
• Antibody-Oligonucleotide Conjugate (AOC) development
• Aseptic fill-finish manufacturing with AST GENiSYS® C multi-format system capable of filling vials, syringes, and cartridges (480 units/hour for 1 mL vials; hand-filling up to 2,000 vials; automated fill-finish up to 10,000 vials)
• Analytical method development, assay verification, and characterization
• Stability testing services

Support Services

• Manufacturing strategy development and biomanufacturing planning
• Project management with transparent, proactive oversight
• Regulatory & CMC support for IND filings and regulatory submissions
• Quality control and quality assurance programs aligned to cGMP (21 CFR Parts 210 and 211)

Facilities & Capacity

GBI's expanded Florida facility (38,000 ft²) includes:

• 5,000 ft² extended warehouse space
• Three dedicated process trains with 200 L, 500 L, and 2,000 L bioreactors
• Process development lab with small-scale bioreactors and purification systems
• cGMP manufacturing core with commercial fill-finish capability
• QC release lab and protein characterization lab

The facility was expanded in 2023 to support multi-product commercial cGMP manufacturing and launched first commercial products on behalf of clients in 2023.

Applications

GBI serves companies developing complex biologics, biosimilars, and bioconjugated therapeutics, with particular expertise in targeted delivery systems with multiple functionalities.