BiOS
Process Design Assessment
Aurelia BioWorks
Excerpt · Design readiness gate
Confidential · Sample
Is the process design ready for later-stage scale-up?
Aurelia’s downstream design is well documented through capture and polish. This excerpt evaluates readiness to hand the package to scale-up engineering—scale factors, hold-time strategy, and control strategy completeness.
| Gate criterion | Status | Evidence | Gap |
|---|---|---|---|
| Scale-down model qualified for critical steps | Partial | Capture column model locked | Viral filtration scale factors still provisional |
| Hold times defined for all intermediate pools | Weak | Draft table in tech transfer pack | No worst-case microbial hold study plan |
| Control strategy linked to CQAs | Strong | CQA–CPP matrix v3 reviewed | Two CPPs lack proven acceptable range at target scale |
| Raw material specs support multi-lot supply | Partial | Primary resin vendor locked | Secondary filter vendor not in design BOM |
Readiness call
Not ready to freeze for detailed engineering until hold-time strategy and viral filtration scale factors are closed—or explicitly deferred with risk acceptance by Tech Ops leadership.
Full sample includes unit-op narrative and open-issue log (not shown).