Case study

Orthogonal HCP analysis for vaccine development

"This HCP analysis saved us the development of a new ELISA that may not have worked"

Statens Serum Institut was looking for an ELISA alternative to cover the process-related impurities in their vaccine better. Today, they utilize LC-MS-based analysis and the resulting list of individual HCPs for their process development and comparison between vaccine batches.

Statens Serum Institut (SSI) used immunochemical assays to analyze 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.


About SSI

SSI is under the auspices of the Danish Ministry of Health, and 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 other necessary preparedness supplies. A close collaboration between SSI, Alphalyse, and the Protein Research Group at SDU improved their HCP analysis.


The collaboration’s outcome: Comprehensive HCP analysis

The collaboration group developed an orthogonal method, which provided additional information about the HCPs obtained from process-specific ELISA. Specifically, the HCP analysis delivered SSI with the identity and quantity of the individual HCPs. Thus, the new method 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. It provided detailed knowledge about the amounts of individual host cell proteins and how to eliminate them during the downstream purification. An understanding that SSI could not obtain from any commercial or process-specific ELISA HCP assay.

SSI logo

‘The Alphalyse HCP analysis saved us the development of an ELISA assay that may not have worked anyway. The HCP team provided very competent explanations of test results and was very open in discussing the method capabilities.’

Max Kristiansen, MSc, Special Consultant Assay Development

Statens Serum Institut (SSI), Denmark

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