BiOS
Operational Scale-Up Assessment
NovaCell Therapeutics
Excerpt · Executive Decision Summary
Confidential · Sample
1. Executive Decision Summary
NovaCell is moving a perfusion-based mAb process from development toward early clinical manufacturing readiness. Technical process definition is ahead of the operating system required to run it reliably: material planning, release interfaces, and ownership of cross-functional decisions remain underspecified.
Decision required this quarter
Prioritize a single “scale-up operating path” for the next 90 days—freeze the materials / release / scheduling interfaces before committing additional process characterization spend.
| Priority | Finding | Why it matters | Suggested move |
|---|---|---|---|
| P0 | Drug substance material demand model not linked to campaign calendar | Lead-time exposure on critical media/filters will slip first tox lot | Build a 2-campaign material risk register with dual-source flags |
| P0 | QC release ownership unclear between NovaCell and CMO partner | Release lag becomes the de facto schedule constraint | Name a single release decision owner + SLA for CoA exceptions |
| P1 | Equipment capacity model assumes ideal changeover | Suite utilization overstated by ~18% in draft plan | Re-baseline changeover + buffer prep window with MSAT + Ops |
Full sample continues with Current→Future Operations Map, Gap & Risk Assessment, and Now/Next/Later roadmap (not shown).