cGMP Bioreactor Production

GBI utilizes three different bioreactor technologies for manufacturing of MAbs (IgGs and IgMs) and recombinant proteins:

GBI offers fully compliant upstream GMP manufacturing for your clinical trial material through Phase II. Bioreactors capable of producing from 1 to over a 100 grams per lot are available.

Perfused Fibracell Disk Bioreactor
Bioreactor volumes from 1.2L to 10L with corresponding bed volumes ranging from 600mL to 4900mL are available. The larger of these bioreactors can produce in excess of 100 grams during a six week production run.

Perfused Hollow Fiber Bioreactor
Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m 2 are available. The larger of these bioreactors can produce in excess of 150 grams during a six week production run.

Batch or Fed-Batch Bioreactor
Stirred tank bioreactors up to 500L are available for these process types. With yields of approximately one gram per liter possible, these bioreactors would produce 500 grams per every 8 to 10 day run.

(Yield is dependent on individual cell line expressions and the values given are for "moderate" or "average" producers.)

The GBI Advantage

• GBI has over 15 years experience with the process development and operation of GMP bioreactor systems.
• GBI's experience includes the continuous operation of GMP perfusion bioreactors routinely for six weeks and in some cases in excess of 60 days (over 8 weeks).
• Material manufactured in bioreactors at GBI has been used for filing over 20 INDs during the past 15 years for Phase I clinical trials.