Method for HCP ELISA assay validation

Collaboration with: Hansa Medical AB (Sweden) and SDU – University of Southern Denmark
Funded by: Eurostars 2017-2019

HCP coverage analysis – coverage information of individual HCPs >>

ELISAs are only 30-70% accurate

Actually, HCP ELISA kits typically only measure 30-70% of residual host cell proteins (HCPs) in biopharmaceutical proteins. And probably worse, you don’t know which ones they miss. Thus it is difficult to perform a proper validation of HCP levels with a random ELISA. Therefore, Alphalyse set out to develop new and better methods for HCP ELISA validation. 

Validation of the individual HCP an ELISA assay detects – or misses

We began this project with a vision of providing a detailed comparison of polyclonal antibodies from various ELISA kits.

The aim was to develop methods that provide a HCP antibody Coverage % for each ELISA kit. Not only does this improve your Host Cell Protein ELISA validation: In addition, you get the names of the individual Host Cell Proteins – those which ELISA antibodies detects, as well as those they do not detect. Our methods are based on immuno-affinity purifications by ELISA antibodies. We combine them with Alphalyse’ unique SWATH LC-MS/MS analysis for HCP identification and quantification.

A close collaboration with leading scientist in immuno-affinity purification and sensitive mass spectrometry at the University of Southern Denmark, Associate Professor Søren Werner Karlskov Hansen and Professor Blagoy Blagoev has been set up. Also, the methods were tested in close collaboration with Hansa Medical, Sweden. Hansa Medical develops immunomodulatory enzymes for treatment of autoimmune conditions and transplant rejection.

Learn how the new method provides you with better coverage information in this 30-minute webinar >>

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