From Mind To Market - Boehringer Ingelheim

Microbial fermentation technology
Boehringer Ingelheim RCV GmbH & Co KG
pioneered the microbial fermentation and
purification of therapeutic proteins from E.coli
since 1982. Over the last decades the company’s
expertise and experience broadened to the development
and manufacture of gene therapeutics,
antibody fragments and protein scaffolds using
E.coli and yeast high expression technologies.
More than 500 skilled people of the Vienna plant
are dedicated to biopharmaceutical production
using microbial systems. The Process Science
Team has built high value Intellectual Property
for efficient and robust processes and is experienced
in process transfer and optimization. Business
process excellence guarantees continuously
innovative technologies improving process economy,
robustness, product safety and quality.
To secure an outstanding combination of scientific
know-how with state-of-the-art technology,
Boehringer Ingelheim Austria operates three
independent fermentation plants for E.coli and
yeast technologies: one medium-scale facility
with 300 litres and two large scale facilities with
6,000 litres. Both, batch and fed-batch fermentations
are performed. The new facilities allow
maximum flexibility and are designed for high
cell density processes requiring high oxygen
demand and high heat exchange. All plants are
operated by a validated process control system.
For downstream processing the purification plant
provides nine separate purification suites, varying
in size from 42 m2 to 280m2 where the processes
can be performed at room temperature
or 2 to 8 °C. Tanks up to 5,000 litres allow the
handling of large volumes during downstream
processing.
Furthermore, explosion-proof areas are in place
to allow steps requiring the use of organic solvents
or large scale high performance liquid
chromatography. Columns range up to 1.6 meter
diameter and techniques such as affinity chromatography,
size exclusion, hydrophobic interaction,
ion exchange, or reversed phase HPLC are
employed.
The plants are approved “multi-product” facilities
for the manufacture of products registered
with the Austrian Health Authorities, the EMEA,
MHLW and the FDA. Products are produced
under cGMP compliance for clinical trials and for
worldwide market supply.
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