Breaking the Status Quo: Using Mass Spectrometry to Identify and Quantify Host Cell Proteins

WEBINAR

Trace amounts of host cell proteins can be present after the production and purification of any biopharmaceutical. Detection of these species requires highly specific techniques to accurately quantify even low levels of contamination. Host cell protein impurities, present at PPM levels in biotherapies, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. Their complex and diverse nature makes them challenging to detect or monitor. With acceptance criteria for host residual DNA usually set at a very low level (often ≤1.0 pg of DNA per mg of drug substance), effective removal techniques and sensitive methods of detection are critical.

Antibody-based techniques, like the enzyme-linked immunosorbent assay (ELISA), have been used to assess the HCP load of biotherapeutics before and after process changes. However, these techniques do not necessarily detect qualitative changes in the HCP population. In this webinar, we will discuss how mass spectrometry (MS)-based approaches coupled with ELISA methods help detect qualitative and quantitative differences in HCP populations.

In this webinar, you will learn:

• Comprehensive HCP ID and semi-quantitation
• HC agnostic process
• Creation of process-specific database
• Differential clearance of specific HCPs throughout purification steps
• Monitoring of problematic species e.g. immunogenic (PLBL2), lipases, and proteases
• Explanation about why 90% of BLAs filed included this HCP MS data