Collaboration with: Hansa Medical AB (Sweden) and SDU – University of Southern Denmark
Funded by: Eurostars
Time period : 2017-2019
How accurate is an ELISA? 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 offer a better measurement – by developing new methods for HCP ELISA validation. We began this project with a vision of providing a detailed comparison of polyclonal antibodies from various ELISA kits.
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 are tested in close collaboration with Hansa Medical, Sweden. Hansa Medical develops immunomodulatory enzymes for treatment of autoimmune conditions and transplant rejection.
The aim is developing methods that provide a HCP antibody Coverage % for each ELISA kit. Not only will this improve your Host Cell Protein ELISA validation: In addition, you will 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.