Hi Sugata Roychowdhury

So the three most common techniques for HCP detection and quantitation are ELISA (either platform-specific or somewhat generic like the Cygnus kit mentioned), 2D electrophoresis and Western Blotting or mass spec. It's recommended to use at least 2 out of three of the techniques to compensate for each technique's limitations, especially when it comes to the generation of novel biotherapeutics which at some point will require FDA clearance. They will want to see data from at least 2/3 techniques and currently the guidance for that is 2D WB data + ELISA data.

We have a more comprehensive breakdown of the techniques in a guidance document on our website here: https://totallab.com/resources/2d-dige-vs-elisa-vs-aae-for-hcp-analysis/

And at least one Janssen site (Philadelphia) is already using our SpotMap software for their 2D anti-HCP coverage analysis and have been for a few years now so perhaps you could reach out to a contact there to see if there's a company-wide SOP to cover this? If you want a direct email contact please use our support form on our website to contact me directly (or direct message me on here) as I don't want to expose that persons email address to the internet at large and risk them receiving unsolicited emails.

Best wishes,

Steven

Thank you Steven and I agree with you. I will definitely check with our HCP Team to get more details initially and if not reach out to you. @Steven Dodd