Statens Serum Institut was looking for an ELISA alternative that could provide more details about process-related impurities. Today, they benefit from the Host Cell Protein analysis in their process development and comparison between vaccine batches.
Statens Serum Institut (SSI) used immunochemical assays for analysis of Host Cell Proteins (HCPs) in drug substances. However, they found that these methods had limited coverage, which resulted in a lack of detail and accuracy. They were thus looking for an ELISA alternative for HCP analysis.
SSI is under the auspices of the Danish Ministry of Health. SSI is responsible for the purchase and supply of vaccines to the Danish national vaccination programs. These include the Childhood Vaccination Program, pandemic preparedness, and also other necessary preparedness supplies. To improve their HCP analysis, a close collaboration between SSI, Alphalyse and the Protein Research Group at SDU began.
The collaboration’s outcome: Comprehensive HCP analysis
Together, the collaboration group developed an orthogonal method, which provided additional information about the HCPs obtained from process-specific ELISA. Specifically, the HCP analysis provided SSI with the identity and quantity of the individual HCPs. This made it possible to compare and identify differences between various production batches.
In addition, SSI found that the mass spectrometry method was applicable for process development. Here it provided detailed knowledge about amounts of individual host cell proteins, and how to eliminate them during the downstream purification. A knowledge, SSI could not obtain from any commercial or process specific ELISA HCP assay.