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Boehringer, BioGenes Sign Assay Alliance

BioGenes to develop product-specific HCP assays for late stage drugs

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By: Tim Wright

Editor-in-Chief, Contract Pharma

BioGenes 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 part of release testing and regulatory compliance documentation. HCPs can still be present even after the last purification step of the drug substance. BioGenes develops highly sensitive HCP assays designed to 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.

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