From Mind To Market - Boehringer Ingelheim

Mammalian cell culture technology
The 1 st multiproduct mammalian cell culture
facility at Boehringer Ingelheim Pharma GmbH
& Co. KG in Biberach was built in 1985 for the
commercial production of recombinant DNAderived
tissue plasminogen activator (rt-PA),
actilyse®. The story of the building is in itself an
example of our corporate will to succeed. The
entire project, from the empty site to the first
production of rt-PA, took only 18 months.
The pilot plant has a scale-up capacity of up to
2,000 litres fermentation volume and is used
for process development and for manufacture
of pre-clinical and clinical material. All relevant
disciplines for the establishment of a process are
integrated in our process science department,
facilitating technical transfer and making it as
economical as possible.
To ensure consistency in product quality during
up-scaling and clinical development, the fermentation
technology and the geometry of the
bioreactors are kept identical in the pilot and the
commercial multiproduct manufacturing plant.
Therapeutic proteins for advanced clinical trials
and for market supply are produced in the manufacturing
buildings under cGMP compliance.
Here the scale-up capacity ranges from 80 to
15,000 litres per fermentation train. With six
fermentation trains installed, the total volume
amounts to 90,000 litres downstream processing
is matched to the scale of fermentation.
Boehringer Ingelheim Pharma GmbH & Co. KG
in Biberach, Germany, expanded its cell culture
capacity with additional six fermenters of 15,000
litres volume each and corresponding downstream
capacity. The construction was completed
in 2003 and received regulatory approval in 2004.
The fill & finish operations were adjusted to the
enlarged manufacturing capabilities.
The total working volume of the mammalian cell
culture facility is now 180,000 litres.
At the plant there are today 1,600 skilled operators
promoting the biopharmaceutical business.
Specialists include biotechnologists, biochemists,
biologists, chemists, engineers, pharmacists and
others.
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