How to determine the purity of your vaccine?

The best way to characterize the impurities of your biologic

A lot of the latest vaccines and other pharmaceutical products consists of biological molecules. The production process of these biopharmaceuticals causes process-related impurities like host cell proteins (HCPs). These HCPs can interfere with product stability or cause safety risks to patients and removal of these impurities is an essential part of the downstream process. LC-MS based approaches are excellent tools to monitor the purification process as these provide excellent sensitivity together with protein specific identifications.

We present highly sensitive HCP identifications using NIST mAb reference material as sample. A high number of protein identifications is shown using the Bruker timsTOF Pro 2 utilizing parallel accumulation-serial fragmentation (PASEF®) functionality with the new VIP-HESI source. In addition, the gain in confidence provided by reliable Collisional Cross Section (CCS) values of identified peptides provided by trapped ion mobility spectrometry (TIMS) technology is shown.

Presenter: Dr. Eric van Beelen (Bruker Nederland BV, Netherlands)