Upstream Manufacturing
GBI utilizes three different bioreactor technologies for manufacturing of MAbs (IgGs and IgMs) and recombinant proteins:
GBI offers fully compliant upstream cGMP
manufacturing for your clinical trial material
through Phase II. Bioreactors capable of
producing from 1 to over 500 grams per lot are available.
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.)
Perfused Hollow Fiber Bioreactor
Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m2 are available. The larger of these bioreactors can produce in excess of 150 grams during a six week production run.
Perfused FibraCell Disk Bioreactor
Bioreactor volumes from 1.2L to 10L with corresponding bed volumes ranging from 600mL to 4,900mL are available. The larger of these bioreactors can produce in excess of 100 grams during a six week production run.
The GBI Advantage
GBI has experience with process development and operation of
cGMP bioreactor systems since 1992.
cGMP production available in
200L and 500L stirred tanks (fed batch) as well
as 100L disposable WAVE bioreactor.
GBI's experience includes the continuous operation of
cGMP perfusion bioreactors routinely for six weeks and in some cases in excess of 60 days (over 8 weeks).
