Bavarian Nordic Covid19 vaccine - how they implemented LC-MS-based Host Cell Protein Analysis

Vaccines are our strongest defense against infectious diseases – making timely regulatory approvals critical for epidemic preparedness.

Western, Eastern, and Venezuelan equine encephalitis (WEV) remain among the dangerous diseases with no approved vaccines.

Caused by mosquito-borne viruses, WEV affects both humans and animals, causing severe neurological illness. Outbreaks have occurred in South America, Central America, and the United States.

Developing a vaccine for WEV is essential to reducing outbreak risks and closing this gap in global health security.

However, WEV is caused by multiple virus types and subtypes, giving viral-based vaccines a complex protein profile that makes impurity monitoring challenging.

Additionally, traditional impurity analysis methods, such as ELISA for Host Cell Proteins (HCPs), often require lengthy development times.

To overcome these challenges, Bavarian Nordic opted for LC-MS analysis to identify and quantify process-related impurities in their WEV vaccine candidate.

On their behalf, Alphalyse developed and qualified an LC-MS method for control and documentation of HCPs in samples for clinical phase 2.

This method offers high sensitivity and reproducibility, making it especially well-suited for quality-controlled analytics in complex viral vaccine development.

Read more about our analytical services for vaccines: alphalyse.com/vaccines