Method for HCP ELISA assay validation

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

Click for info on HCP coverage analysis – coverage information of individual HCPs >>

ELISAs are only 30-70% accurate.

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 isn’t easy to properly validate 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 kits.

The aim was to develop a method that provides an HCP antibody Coverage % for each 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, 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 methods in close collaboration with Hansa Medical, Sweden. Hansa Medical develops immunomodulatory enzymes to treat autoimmune conditions and transplant rejection.

In May 2018, we first presented the ELISA-MS method at the BEBPA HCP conference and have since run several projects and further refined the technique.

Learn how the new method provides you with better coverage information >>

Download brochure >>


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