cGMP Clinical & Commercial Manufacturing
GBI offers expertise in multiple cGMP manufacturing bioreactor platforms and scales to address a variety of production modalities including batch, fed batch, and perfusion.
As a full-service CDMO we provide end-to-end cGMP manufacturing, from the creation of drug substances through the manufacture of drug products including monoclonal antibodies (mAbs), vaccines, and antibody drug conjugates (ADCs).
GBI currently offers two independent upstream process trains consisting of dedicated inoculation and bioreactor suites with common downstream pre-viral and post-viral suites.
- Dakota Systems 200L and 500L stainless steel bioreactors with dedicated CIP and Pure Steam skids
- Cytiva XDR-200 200L single-use bioreactor and Sartorius Biostat STR 500 Gen3 500L bioreactor capable of perfusion with the use of Repligen XCell ATF 6 and ATF10
- Supporting cell expansion equipment, including Thermo Fisher Forma Steri-Cult CO2 incubators and 2D rocker platforms as well as 25L working volume by Cytiva and Sartorius
- Purification suites outfitted with ÄKTA™ ready and ÄKTA™ Process 10mm chromatography systems and Repligen, Sartorius, and Millipore TFF hardware
- 2,000 L single-use Sartorius bioreactor, to be installed in 2023
The scale of the bioreactor selected depends on the cell line’s productivity and the volume requirements for the cGMP material. Once the cGMP material is produced, GBI performs in-process and release testing as well as a QA review of the manufacturing documentation. We also offer the creation of a reference standard to help you meet regulatory compliance needs.
The Future of Commercial cGMP Manufacturing at GBI
We are expanding the GBI facility through 2023 to support multi-product commercial manufacturing. The expansion will result in our having three independent process trains, each including inoculation, bioreactor, pre-viral, and post-viral suites.
The process trains will be outfitted with the following process skids:
- Cytiva XDR-200 (Repligen ATF 6) paired with the ÄKTA™ ready gradient chromatography system
- Dakota Systems 200L and 500L paired with the ÄKTA™ Process 10mm gradient chromatography and Sartoflow TFF systems
- Sartorius Biostat STR Gen3 200L, 500L (Repligen ATF 10), and 2000L paired with the Sartorius Allegro chromatography and Sartoflow TFF systems