Live webinar: ELISA reagent characterization

The use of HCP-ELISAs carries several risks:

❌ Perhaps the mock sample used for immunization isn't representative of the harvest sample

❌ Perhaps a few residual proteins are particularly immunogenic and skew the resulting antibodies

❌ As a result, the ELISA may not measure abundant or problematic HCPs, or those homolog to the drug

Therefore, authorities ask for a characterization of the ELISA reagents.

It means you must demonstrate the reagents' suitability for your manufacturing process and product. Otherwise, the authorities can halt your project or even ask that you change your manufacturing process.

On the other hand, it also means that you don't have to develop a process-specific assay if you can thoroughly demonstrate that a commercial ELISA is fit-for-purpose.

For example, one of our clients received FDA approval for their BLA using a commercial ELISA kit to monitor and document HCPs. It was possible because they used our data to demonstrate that it fits the HCPs of their product perfectly.

The point is that sometimes a commercial ELISA is perfect for your process and product, while you need to develop a process-specific assay at other times. In either case, you should document that your assay covers most HCPs and specific HCPs (e.g., those with enzymatic activity).

Curious to learn more?

📆 Join Ejvind Mortz's webinar June 28 to learn why and how to demonstrate that your ELISA reagents are fit for purpose >>