Date: 2012-06-14
Type of information: Services contract
Compound: host cell protein (HCP) assays for late stage drug substances
Company: BioGenes (Germany) Boehringer Ingelheim (Germany)
Therapeutic area:
Type agreement: services
development
Action mechanism:
Disease:
Details: BioGenes, a specialist in immunoassay and sophisticated antibody development, has signed a collaboration agreement with Boehringer Ingelheim to develop several product-specific host cell protein (HCP) assays for late stage drug substances. Product-specific HCP assays are usually required in clinical phase III studies to demonstrate consistency of manufacturing.
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.
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