Better method for HCP ELISA validation

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

Click for info on our HCP coverage analysis services – which includes coverage information of individual HCPs >>

ELISAs are only 30-70% accurate

HCP ELISA kits typically only measure 30-70% of the residual host cell proteins (HCPs) in biopharmaceutical proteins. And probably worse, you don’t know which ones they miss. Thus it isn’t easy to properly validate the HCP levels with a random ELISA. Therefore, in 2017 Alphalyse set out to develop new and better methods for HCP ELISA validation that could solve these challenges and provide much better data.

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 a method that provides an HCP antibody Coverage % for each ELISA kit. Our practices are based on immuno-affinity purifications by ELISA antibodies. We combine them with Alphalyse’s unique SWATH LC-MS/MS analysis for HCP identification and quantification to improve your Host Cell Protein ELISA validation. In addition, with this type of assay, you get the names of the individual Host Cell Proteins – those which ELISA antibodies detect and those they do not see.

The project included a close collaboration with the 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. Also, we tested the new methods in close collaboration with Hansa Medical, Sweden. Hansa Medical develops immunomodulatory enzymes to treat autoimmune conditions and transplant rejection and was in the early stages of investigating HCPs in the product.

In May 2018, we first presented the ELISA-MS™ method at the prestigious BEBPA HCP conference. Since then, we have run several client projects and further refined the technique so that it is today one of the best coverage analysis offers on the market.

Would you like more information on ELISA coverage analysis?

In this short webinar (30 minutes), you can learn more about how the ELISA-MS™ method provides you with better coverage information. Press the button to start the webinar on-demand.