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The GMP
production unit is designed as a multipurpose facility for the biotechnological
production of protein APIs using microbial expression systems. The process equipment is realised as a closed system in a cleanroom
class 100.000 environment. The cleanroom area is separated into three sections
for service, fermentation and downstream processing, respectively:
The service section
comprises the areas for reception, quarantine, sampling, storage and weighing
of raw materials as well as for cleaning, sterilisation and preparation of
reusable small equipment. In the fermentation section the equipment for media
preparation, fermentation, cell harvest, cell lysis and clarification is
installed. The section comprises stainless steel stirred vessels for media
preparation (1000 litres), fermentation (1000 litres), harvest (1300 litres) as well as
equipment for disk stack centrifugation (500 l/h) and high pressure
homogenisation (500 l/h). -
In the
section for downstream processing stainless steel stirred vessels for refolding
(2000 litres and 300 litres), buffer preparation (2000 litres and 500 litres) as well as the units
for chromatography and UF/DF are installed. A class 100 laminar flow box in a
class 100.000 cleanroom environment is used for bulk filling.
All three
cleanroom sections are controlled by separate HVAC systems. These systems as
well as the utilities for media supply (clean steam, highly purified water,
CIP) and waste water treatment are located in the technical and maintenance
section. The process equipment used for fermentation/upstream
processing and downstream processing, respectively, is hard piped to separate
CIP systems. The CIP/SIP procedures are fully automated.
Facility
short facts:
- 100 L and
1000 L fermentation vessels
- 300 L and
2000 L premium (1.4539) steel refolding vessels
- Three separate
HVAC systems and two separate CIP systems
- Completely closed,
hard-piped system from fermentation over cell harvest and cell disruption to
refolding vessels
- Disk stack
centrifuge and two ultrafiltration/diafiltration devices
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