BioGenes GmbH has 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 in house 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.