GBI's 2023 Expansion
A big expansion is coming to GBI’s Florida facility in 2023, with equipment being put in place for multi-product commercial cGMP manufacturing.
The 38,000 ft2 manufacturing and process development facility will include:
- 5,000 ft2 of extended warehouse space
- 200L, 500L and 2,000L bioreactors (with three dedicated process trains)
- Fill finish hand-filling up to 2,000 vials
- Automated fill finish up to 10,000 vials
With product development and tech transfer capabilities, a QC release lab, and a protein characterization lab the expanded facility will be ready for commercial operations in 2023 Q2.
GBI’s Process Development Lab
Our award-winning process development lab is fully equipped with:
- Stirred tank batch and fed-batch bioreactors
- Stirred tank bioreactors ranging from 250mL to 40L
- Multiple 5L stirred tank bioreactors — We offer access to small bioreactor systems of each type for the development of specific run parameters and scaling data for the larger production bioreactors. These small systems are also available to produce non-cGMP material for testing and toxicology studies
- Fibra-Cel disk immobilized bed perfusion bioreactors are available in both the Process Development Lab (XCell™ ATF 2) and cGMP core (XCell™ ATF 6) for perfusion and continuous processing
- Several ÄKTA™ systems for downstream purification
- Mettler Toledo Advanced Synthesis system for controlled and scalable bioconjugation processes
Our process development lab works closely with our manufacturing team to ensure a seamless transfer to our larger scale bioreactors in the cGMP core facility.
Aseptic Fill and Finish Manufacturing Equipment
Our facility is equipped with a multi-format AST system for filling and crimping, GENiSYS® C with Vial-Sealing Module (VSM-10). This system is capable of filling, stoppering, and crimping ready-to-use (RTU) vials, syringes, and cartridges when equipped with the appropriate tooling. The equipment is intended for the cGMP (21 CFR parts 210 and 211) liquid filling and closing. It also features electronic batch reporting (EBR) capabilities.
The AST GENiSYS® C multi-format aseptic filling machine has these primary functions:
- Vials and syringe: With one needle filling, 480 units per hour can be achieved for a 1mL water fill into a 2R vial at 2% IPC followed by a serum stopper close (assuming 20 seconds for nest handling).
- Accuracy: The standard deviation for peristaltic dosing of water will be:
- ± 1.0% from 0.5mL – 3.0mL fill volumes
- ± 0.5% from 3.0mL – 50 mL fill volumes