Problematic Host Cell Protein impurities can stop your biologic program!

Which HCPs to look for and how to measure them

Residual HCPs in a drug product can impact patient safety and product stability. In several clinical trials and during the development of many biologics, specific HCPs, such as flagellin, proteases, and the infamous PLBL2, have proved problematic. Some HCPs cause immunogenicity in patients, some HCPS cause unwanted biological effects, and some HCPs can enzymatically degrade the drug itself, decreasing its efficacy and shelf life.

For mAbs, one of the most well-characterized groups of biologics, it is now well-described which HCPs from the CHO expression system you should be concerned about. Regulatory guidelines assert that the documentation should include risk assessments of individual HCPs identified and removed during purification.

Get an introduction to:

• Examples of bad actor HCPs that have resulted in clinical hold – and even shut down drug development programs
• The main groups of harmful impurities you should watch out for
• LC-MS-based techniques to identify and quantify HCPs of concern