ELISA test to confirm elimination of Host Cell Proteins (HCP) from bioproductions

ELISA test for host cell proteins

Expression systems – removing their contaminants

CHO, E. Coli and Pichia are useful expression systems for drug production. This can be for proteins, enzymes or antibody productions. Research and development for therapeutic perspectives requires a high level of quality controls. Such expression systems contain +1000 host cell proteins (HCPs). A major challenge in biological component production is to remove this HCP contamination. In order to monitor removal efficiency (during protein purification, as mentioned further on in this article), Canopy Biosciences have developed and optimised HCP detection kits based on the principle of the sandwich ELISA test as illustrated below.

ELISA test to detect host cell proteins - Canopy Biosciences

Principle of the HCP Detection assay is based on sandwich ELISA test – by Canopy Biosciences at tebu-bio.com

High sensitivity detection and quantification of the HCP

The assay uses a standard for quantification. Thus, these sandwich ELISA tests are highly sensitive and provide concentrations of HCP. They can be used during the protein purification process in order to monitor and optimize that step of the bioproduction workflow.

CHO protein standard curve - HCP quantification ELISA test

CHO protein standard curve – HCP quantification ELISA test

There is a specific kit for each expression system: CHO, E. Coli and Pichia. For residual protein A in antibody production there is also a dedicated kit. Each kit allows quantification of up to 24 samples.

Of course, these HCP ELISA tests must be highly reproducible. Thus, variation coefficients are especially low as illustrated below with the CHO version.

What are the advantages of these Canopy HCP detection kits vs standard kits?

  • 25% more coverage (CHO HCP antibody coverage is 251/348= 72%)
  • 5 to 10 times more sensitive (contact me, I’ll be pleased to go into more detail)
  • Lower lot-to-lot variations
HCP detection ELISA test - variation intra-assay

Low coefficient of variation intra-assay with Canopy HCP detection ELISA tests

Low inter-assay variation

High reproducibility from lot-to-lot

Since the technology is based on an ELISA test, the quantification can be done using our tips and analysis tool available to download here. If you have any questions or would like to know more, just leave any comments below and I’ll be pleased to answer!

Written by Dimitri Szymczak, PhD
Dimitri Szymczak is a Technical Support Specialist and Product Manager at tebu-bio, and a fan of capoeira in his spare time.