From Mind To Market - Boehringer Ingelheim

powder. This system is suitable in particular for
high doses or drug substances not sufficiently
stable in solution.
The technology portfolio of Boehringer Ingelheim
biopharmaceuticals also contains non-viral
gene vectors for in vivo application of genes. We
develop special DNA cationic lipid complexes
and DNA entrapped in resomer® particles. The
particle size and composition are optimized
to transfer genes efficiently without toxic sideeffects.
Analytical development and
quality control
Protein analytical chemistry is constantly evolving.
Improvements are continuously being made
with respect to the sensitivity and selectivity of
analytical assays. The most advanced analytical
tools are applied to ensure the concept of “well
characterized biopharmaceuticals”. The selection
of appropriate methods at each stage of development,
from early development to registration, is
essential for success.
Using protein analytical chemistry, we character-
ize the primary structure of complex proteins
and monitor the potential impact of process
optimization and scale-up on the product quality
in accordance with worldwide regulatory guide-
lines.
Thereby we ensure the equivalence of biopharma-
ceuticals, thus reducing the need for lengthy
and expensive clinical investigations.
EMEA/FDA approval and more
The multiproduct manufacturing facilities at
Biberach and Vienna are inspected by the Euro-
pean Medicines Evaluation Agency (EMEA),
the FDA, and Health Canada. They hold the license
for a number of products. All plants meet the
requirements of the World Health Organization
(WHO) and the Pharmaceutical Inspection
Convention (PIC). Additionally, the facilities
are subject to regular scrutiny by the health
authorities, consultants and quality assurance
units of our partners. The company’s policy is
to maintain a high level of compliance.
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