---
name: GBI Biomanufacturing
slug: gbi-biomanufacturing
site: cdmo
website_domain: gbibio.com
summary: Full-service biologics CDMO offering integrated development and manufacturing services including cell banking, upstream/downstream processing, bioconjugation, aseptic fill-finish, and regulatory support for complex biopharmaceuticals. Headquartered in Plantation, United States.
tagline: Full-service biologics CDMO with integrated development and manufacturing from cell banking through commercial fill-finish.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-09-21T00:02:27.928Z
services_count: 14
modalities_count: 3
indications_count: 0
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# GBI Biomanufacturing

Full-service biologics CDMO with integrated development and manufacturing from cell banking through commercial fill-finish.

Listed on cdmo.directory.

## Summary

Full-service biologics CDMO offering integrated development and manufacturing services including cell banking, upstream/downstream processing, bioconjugation, aseptic fill-finish, and regulatory support for complex biopharmaceuticals. Headquartered in Plantation, United States.

## At a glance

- HQ country: US

## Services

- CMC Analytical Development
- Cell-Line Development
- Upstream Processing
- Downstream Processing
- Stability Testing & Storage
- Bioconjugation Services
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Quality Control Testing
- CMC Regulatory Submission Support
- Technology Transfer
- Recombinant Protein Manufacturing

## Modalities

- Biologics (Other)
- Biologics (Monoclonal Antibodies)
- Oligonucleotide

## Locations

- Headquarters & Manufacturing, Plantation, Florida, USA

## Long description

## 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.

## Related companies

- [Samsung Biologics](/companies/samsungbiologics) (CMC Analytical Development, Cell-Line Development) — [Compare](/compare/gbi-biomanufacturing/samsungbiologics)
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- [Vetter Pharma](/companies/vetter-pharma) (CMC Analytical Development, Stability Testing & Storage) — [Compare](/compare/gbi-biomanufacturing/vetter-pharma)
- [Wheeler Bio](/companies/wheeler-bio) (CMC Analytical Development, Cell-Line Development) — [Compare](/compare/gbi-biomanufacturing/wheeler-bio)
- [KBI Biopharma, Inc.](/companies/kbibiopharma) (CMC Analytical Development, Cell-Line Development) — [Compare](/compare/gbi-biomanufacturing/kbibiopharma)
- [Pfizer CentreOne](/companies/pfizercentreone) (CMC Analytical Development, Stability Testing & Storage) — [Compare](/compare/gbi-biomanufacturing/pfizercentreone)

_Profile last updated: 2026-09-21T00:02:27.928Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.