Leadership Guide
The Potency Matrix
Even experienced teams underestimate how unresolved the question of potency really is in CGT development.
What the Framework Reveals
Why no single assay can capture what these therapies actually do
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most complex analytical challenge in CGT, by MKA's own assessment
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FDA guidance documents this paper is built on (21 CFR 600.3(s) + Potency Tests guidance)
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how often a single potency assay is scientifically sufficient
Traditional pharmaceuticals can often correlate potency to a concentration measurement. CGT products can't — a CAR-T therapy has to display its construct, recognize a target, activate an immune response, and kill cancer cells, and no single assay captures that whole chain. This paper, the first in MKA's CGT technical explainer series, breaks down why regulators expect a full "assay matrix" instead of one test, and why potency assay development can't be deferred to late-stage without serious downstream risk.
Source: Pages TBD · Jan 2026 · MKA-19-WP, Executive Summary
Built for: CGT manufacturing and quality leads.