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Facility & scale-up risk pulse

Five questions. Instant band. Not a full risk assessment — that stays with diligence / BiOS engagement. For manufacturing feel, also try Line Balance Lab.

Are USP / DSP / QC interface owners named and accountable?

Yes — documented and livedNamed on paper onlyAmbiguous / rotatingNot defined

Do titer / batch plans match DSP and QC capacity evidence?

Linked mass & capacity modelPartial — one side laggingAspirational slides onlyUnknown

Can QC release keep up if batch cadence increases 30%?

Modeled and staffedTight but plausibleWould create a queueWould break

Facility / utilities / cleanroom constraints for the next campaign?

Risk register with ownersKnown but unfunded mitigationsTribal knowledge onlyNot assessed

Does leadership have a Now/Next/Later freeze for this quarter?

Yes — decisions stickList exists, still debatedEverything is Priority 1No freeze mechanism

Facility & scale-up risk pulse

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