From Mind To Market - Boehringer Ingelheim

18
We have the expertise
Value and quality through innovation
Process sciences
Process sciences covers the Boehringer Ingelheim
biotechnical development and pharmaceutical
development chain. Moreover, it guarantees
Boehringer Ingelheim a constant supply of innovative
technologies improving process economy,
robustness, product safety and quality.
Drug substance development
The starting point of the biotechnical development
chain is the host cell expression system
development based on Boehringer Ingelheim’s
high expression vectors and high-throughput
clone selection to obtain robust high-producing
cells in shortest time. Based on the cultivation
of these cells, further activities in media design,
process and purification optimization lead to
an economic and robust basic manufacturing
process ready for scale-up.
With this integrated concept titres for monoclonal
antibodies of more than 4 g/litre have
been achieved. In the pilot facility optimization
of technical parameters and cGMP production
of clinical materials is conducted. For perfor-
mance of registration batches and production of
marketed material the processes are transferred
to the large-scale manufacturing facilities.
Drug product development
In the pharmaceutical development chain we
have the expertise and the technical possibilities
for the development and production of
clinical supplies of different dosage forms for
biopharma ceuticals.
For parenteral applications we can supply liquid
spray dried or lyophilized preparations in vials,
and ready-to-use syringes.
With two inhalation devices, respimat® and handihaler®,
Boehringer Ingelheim has pro prietary
devices for pulmonary administration
of biopharmaceuticals in liquid as well as in
solid preparations. The respimat® is a highly
innovative pocket size device, which produces
a slow-moving cloud and achieves high lung
deposition. The powder inhaler handihaler®,
likewise pocket size, can deliver up to 50 mg of