The erythrocyte stimulating hormone erythropoetin
(Recormon®) is an endogenous hormone identical
active substance, which is in successful use for medication
of anaemia from dialysis patient. The thrombolytical
reteplase (Rapilysin®) is an recombinant produced
pharmaceutical of the second generation, which optimises
the medication of cardiac infarct. These proteins for
human therapy are produced in two highly sophisticated
bioprocess plants. These production systems are designed
to produce high amounts of biologically active substances.
Using state-of-the-art production concepts, these plants
were designed and built for efficiency. Special consideration
was given to each process step in order to achieve
self-contained, highly automated, recipe-based systems.
The equipment and process flow at the Penzberg facility
incorporate the most current of cGMP principles. The
plants were delivered turn-key by BBI . The following
individual tasks have been performed:
Detailed
design for process equipment and transfer
systems Manufacturing of all fermenters and
process vessels Installation and piping on site Integration of package units from other
vendors (high pressure homogenizer,
separator) Design and Installation of field instrumentation,
using fieldbus technology Specification,
programming and test of control software
(phase logic) and
HMI Software for PLC and SCADA systems Installation of the control system
and performance of qualification tests
(IQ/OQ)