Operating GMP facility in Prague, Czech Republic
SCTbio is
an European CDMO
SCTbio is operating a GMP cell and gene therapy manufacturing facility
in Prague, Czech Republic. The SCTbio has also access to a viral vector manufacturing facility operated by its affiliated company based
in Cambridge, MA, USA.
MANUFACTURING FACILITY
Prague, Czech Republic
Jankovcova 2, 170 00 Prague 7
Czech Republic
4.500 sq. ft.
-
GMP clinical and commercial manufacturing capabilities
-
Class A/B/C/D clean room facility classified according to EU cGMP
-
Autoclaves – laboratory tools, cleaning material sterilization
-
DI water (de-ionized) system – water for autoclaves and cleaning
-
Laundry services outsourced via third party
-
CO2 station with automatic switch – CO2 source for incubators
-
Vacuum pumps – vacuum source for particle counters
-
Five terminal PC with barcode readers in Class C area (LaSSo™ scheduling and raw material system access) plus two terminal PC with barcode readers outside clean premises
-
Cryostorage – five Dewar tanks, LN2 filling unit, automated filling and control
“SCTbio already had an impressive track record of experience with autologous cell therapy manufacturing, including not just GMP manufacturing and analytical capabilities, but a sophisticated cold chain operation, scheduling and supply chain software, and extensive network of qualified leukapheresis sites.”
