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BioGenes to Develop Specific HCP Assay for Boehringer Ingelheim
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.
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.