HCP Assay by commercial ELISA

Measure HCP level with generic assay or process-specific ELISA antibodies

Host cells used for recombinant protein expression, such as CHO, E. coli and HEK 293, contain thousands of proteins (HCPs) that contaminate the purified protein. An HCP assay using an ELISA kit enable fast assessment of the HCP amount. It is suitable for both process samples and the final biopharmaceutical product.

HCP impurities may affect drug safety and they are crucial to remove from your biologic at an early stage. As stated in USP 39 (US Pharmacopeia Chapter 39, 2016) “HCPs should be reduced to low levels”.

A wide range of commercial HCP assay kits are available. We offer to analyze your samples by any of them, e.g. HEK 293, CHO, E. coli, etc. We can also optimize the ELISA protocol to your samples – and provide validation for your process by HCP ELISA coverage analysis.

Which HCP assay services should you choose?

As standard we offer to services, as described below.

Option 1: ELISA HCP analysis of your samples

• We use either a commercial kit (e.g. HEK 293 or CHO) or process specific ELISA antibodies.
• You get an analysis of your process samples or final product.
• Receive a report with the ELISA HCP concentration by email.

Option 2: Optimize and validate ELISA by HCP coverage analysis

We can use any commercially available HCP assay or your process-specific antibodies.

• First, we optimize the ELISA antibody-HCP binding
• Next, the HCPs are immunocaptured with the ELISA antibodies
• Then, the total and affinity purified HCPs are identified by SWATH mass spectrometry
• Finally, you get a report with the HCP coverage percentage and a list of immunocaptured and total HCPs

Send us a request and we will adjust the analysis to meet your specific needs.