Why CDMO Selection Deserves More Due Diligence Than It Usually Gets
Choosing a contract development and manufacturing partner for a Phase I programme is one of the most consequential decisions an early-stage drug developer makes. It shapes your timelines, your CMC package, and your ability to respond when something unexpected happens. Yet many biotech companies spend more time evaluating clinical CROs than they spend evaluating their CDMO.
This checklist covers the questions that experienced drug developers ask when evaluating a CDMO for first-in-human manufacturing. It is not exhaustive, but it addresses the areas where gaps most often lead to problems.
Phase I CDMO Evaluation Checklist
| Evaluation Area | Key Questions to Ask |
| GMP compliance | When was the last regulatory inspection? What were the findings? Is the facility authorised for clinical manufacturing? |
| Quality management system | What is the process for out-of-specification results? How are deviations investigated and closed? |
| Technical capability | Does the CDMO have experience with your dosage form and route of administration? What formulation technologies are available in-house? |
| Analytical services | Can the CDMO develop and validate your release methods in-house? How are stability studies managed? |
| CMC regulatory support | Does the CDMO have experience writing IND/IMPD CMC sections? Can it provide regulatory advice as well as manufacturing? |
| Project management | Who is your primary contact? How is communication structured? What does the escalation path look like? |
| Capacity and lead times | What is the current production schedule? What is the realistic timeline from project kick-off to GMP batch? |
| Supply chain visibility | Where do excipients and starting materials come from? What is the contingency for supplier issues? |
| Track record | How many Phase I batches has the facility produced in the last two years? Can it provide client references? |
| Flexibility for change | How does the CDMO handle formulation changes mid-programme? What is the process for scope adjustments? |
The Questions Most People Forget to Ask
What Happens When the Project Manager Leaves?
In a small CDMO, the quality of your experience often depends on one or two key people. It is worth asking directly what the continuity plan is if your primary contact leaves the organisation during your programme. An organisation with robust knowledge management systems will have a clear answer.
How Does the CDMO Handle Competing Priorities?
CDMOs work with multiple clients simultaneously. When your programme and a higher-priority client need the same piece of equipment or the same specialist at the same time, something has to give. Ask how the CDMO manages competing priorities and what commitments it makes regarding dedicated capacity.
What Does ‘We Can Do That’ Actually Mean?
Some CDMOs have broad service lists but narrow actual capabilities. If a service is listed but has only been performed once or twice, the learning curve comes at your expense. Ask for the number of programmes completed using the specific technology relevant to your molecule.
How Ardena Approaches Phase I Partnerships
Ardena’s Phase I manufacturing capabilities span oral solids, complex injectables, and nanomedicines across its European network. Each programme is managed by a dedicated project manager and supported by a scientific team that has been involved from early development. The CMC regulatory function is integrated, so the team producing your GMP batches is aligned with the team writing your IND or IMPD CMC section.
