WHITE PAPER

ECL-based ADA assays: choosing the right QC strategy for your programme

The QC strategy you set at validation governs how every analytical run is assessed for the lifetime of your study. For bioanalytical scientists and programme managers working with ECL-based ADA assays in CGT, this guide sets out the four validated approaches, with the trade-offs for each.

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Same brief,
different QC strategy

For ECL-based ADA assays, standard QC frameworks were written for quantitative assays. ECL platforms behave differently, causing plate rejection to accumulate over time, creating delays in programmes already under time and budget pressure.

The decisions made at validation, about which acceptance approach to use and why, have consequences that run for the lifetime of a study. Two CROs given the same brief will approach this differently. That is a structural feature of the field, and understanding it is the starting point for managing it closely.

This guide sets out four validated approaches to QC acceptance strategy for ECL-based platforms, with the trade-offs for each, so you can make the right decision for your specific programme from the outset. Getting it right means your data is defensible under regulatory scrutiny, your plates are not being rejected on a technical basis, and the decisions that depend on that data, patient inclusion, safety monitoring, programme timelines, can proceed on schedule.

A decision that impacts
the entire study

QC strategy set at validation
Plate rejection on repeat
Defensible under scrutiny
Patient inclusion & safety
monitoring
Getting QC right helps keep your programme
on track.
“
As a CRO, you have to be clear towards your sponsors, the regulators, the scientists or medical doctors who have to take decisions based on your results. Expertise is the key to confidence.
Sabrina Triffault
Analytical Director, GenoSafe
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ORIGINAL WHITEPAPER

Want the full scientific detail?

Read the original whitepaper by Sabrina Triffault, Analytical Director at GenoSafe, the technical paper behind this guide.

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