I have spent days trying to set up a useful ELISA assay for detecting Host Cell Proteins (HCPs) in my process samples.
I’m concerned about the matrix effects and interference with the HCP-ELISA results from the buffers in the different process steps. Also, an ELISA assay only provides a total HCP amount, but we could really use the quantity of specific HCPs.
Is there an alternative to HCP-ELISA that provides a better, and maybe easier, way to obtain HCP results?
It can be very frustrating to spend valuable time setting up an ELISA assay and then only get imprecise data.
But actually there is better and easier solution, where you:
- spend NO time setting up an HCP ELISA assay.
- simply ship your samples off for analysis by mass spectrometry.
- receive a complete report for each process sample with the total amount of HCP – in just a few weeks.
In addition, you get a list of individual HCPs with their pI, MW data,and quantity (ppm) for easy comparison between process samples.
The new HCP analysis is based on SWATH® mass spectrometry (LC-MS)
It’s so powerful because:
- When your production process changes, the HCP assay can quickly be adjusted.
- The only action needed is running the test and preparing the report (which we do for you).
Here’s how it works:
Over the last 3 years, Alphalyse scientists have developed a fast and informative HCP analysis as an alternative to ELISA. The new analysis is based on SWATH® Liquid Mass Spectrometry (LC-MS) technology.
You just mail your samples, and we adjust the LC-MS assay for your product.
A few weeks later you will receive a complete report and summary table of HCP content, which you can easily share with colleagues or your process development team.
And you can just keep sending new batch samples as your project develop and compare the results with older data-sets.
An HCP assay based on SWATH® LC-MS provides multiple advantages over ELISA assay:
- You receive an identification and quantification of each HCP – So it’s easy to
compare individual HCPs for different process samples and final batches.
- You need no time for immunization or assay development – LC-MS analysis
can be applied directly to your samples.
- It’s robust – Reproducible data is obtained by microflow SWATH® LC-MS.
As a bonus, HCP analysis by LC-MS is applicable for a broad range of samples
– all process steps from dirty sample to final drug product.