We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
BioGenes to Develop Specific HCP Assay for Boehringer Ingelheim
News

BioGenes to Develop Specific HCP Assay for Boehringer Ingelheim

BioGenes to Develop Specific HCP Assay for Boehringer Ingelheim
News

BioGenes to Develop Specific HCP Assay for Boehringer Ingelheim

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "BioGenes to Develop Specific HCP Assay for Boehringer Ingelheim"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

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.

Advertisement