publication date: Jul 5, 2012
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author/source: BioGenes
BioGenes GmbH, a specialist in immunoassay and
sophisticated antibody development, today announced that it has signed a
collaboration agreement with Boehringer Ingelheim to develop several
product-specific host cell protein (HCP) assays for late stage drug substances.
Proof of HCP depletion during the
purification process is an essential part of release testing and the regulatory
compliance documentation. HCPs can still be present at significant
concentrations even after the last purification step of the drug substance.
BioGenes develops highly sensitive HCP assays that can detect HCPs at very low
levels.
"BioGenes will provide on-call assay
development capacities to both speed up the development and disburden
Boehringer Ingelheim's inhouse capabilities," said Dr. Alexander Knoll,
Managing Director of BioGenes.
Product-specific HCP assays are usually
required in clinical phase III studies to demonstrate consistency of
manufacturing. In the early process development phase as well as in early
clinical phases, generic assays available as off-the shelf kits are usually
acceptable.
About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized
antibody and immunoassay development and is an experienced and reliable partner
for process development improvements in all areas of quality control,
diagnostics and drug discovery. BioGenes is certified to meet the international
requirements and regularities of quality assurance and animal welfare. The
Company maintains long-term relationships with research institutes,
universities and biotech and pharmaceutical companies, which include eight of
the ten largest pharmaceutical companies in the world.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 145
affiliates and more than 44,000 employees. In 2011, Boehringer Ingelheim
achieved net sales of about 13.2 billion euro. Since it was founded in 1885,
the family-owned company has been committed to researching, developing, manufacturing
and marketing novel medications of high therapeutic value for human and
veterinary medicine. Today, Boehringer Ingelheim is one of the world's leading
companies for contract development and manufacture of biopharmaceuticals. All
types of services from mammalian cell line or microbial strain development to
final drug production can be delivered within a one-stop-shop concept.
Boehringer Ingelheim delivers services for pre-clinical development up to
global market supply with a strong commitment to its customers at its global
manufacturing facilities for mammalian cell culture and microbial fermentation.
Boehringer Ingelheim has brought 19 molecules to market and has many years of
experience in multiple molecule classes such as monoclonal antibodies, recombinant
proteins, interferons, enzymes, fusion molecules and plasmid DNA. Furthermore,
high-titer platform technologies for new antibody mimetic formats such as
scaffold proteins and antibody fragments are available for the manufacture of
customer products.
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