Why CDMO “Project Governance” Is a Technical Advantage (Not Just Admin)
When sponsors evaluate CDMO partners, they often focus on chemistry capabilities and equipment. That matters. But in practice, many delays come from something else: unclear governance.
Project governance is not a bureaucratic layer. In manufacturing and development, it’s a core system that:
- keeps scope stable
- makes change visible
- ensures decisions are documented
- reduces handoff friction between chemistry, analytics, QA, and the sponsor
Here’s what “good” looks like in a sponsor-friendly CDMO model.
Stage gates: the simplest way to protect timelines
A stage gate is a structured checkpoint that confirms:
- the technical work is ready to progress
- acceptance criteria are met
- documentation and data are complete enough for the next step
Typical gates include:
- Discovery/Scouting: feasibility confirmed
- Scale-up Readiness: route/procedure updated for robustness
- Pilot Phase: pilot run confirms reproducibility
- Production: final production with defined release criteria
- Close-out: documentation package assembled (and sponsor-ready)
Stage gates prevent the most common failure mode: scaling a process that isn’t ready.
Clear deliverables prevent scope creep
Most scope creep is unintentional. It happens when deliverables weren’t explicit, such as:
- “We thought impurity profiling was included.”
- “We assumed stability would be started.”
- “We need plate formatting now.”
- “Our regulatory team needs more detail in the CoA.”
A well-run CDMO engagement defines deliverables early:
- what testing will be performed
- what documentation will be provided
- what is included now vs optional later
- what constitutes “batch success” (acceptance criteria)
Change control protects both sponsor and CDMO
Change control is simply a system for answering:
- what changed
- why it changed
- what the impact is
- who approved it
- how it is documented
This is valuable long before late-stage manufacturing because it keeps the program narrative coherent and reduces rework later.
Communication cadence reduces idle time
Timelines slip when decisions wait in inboxes. A predictable cadence helps:
- weekly or biweekly status updates
- risk register reviews when needed
- rapid escalation pathways for deviations or surprises
- clear “next actions” and owners (sponsor vs CDMO)