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8 Critical Questions for CDMO Selection
Avoiding common outsourcing pitfalls. Selecting the wrong CDMO doesn’t just slow your timeline — it can cost you nine months and your entire launch window. This guide gives you the questions that separate real capability from sales promises.
Selecting the wrong CDMO doesn't just slow your timeline — it can cost you your launch window
A process scheduled for four months can stretch to nine. Tech transfer fails not because the steps aren’t documented, but because process documentation captures what you did — not always why it worked. Pharma companies need to ask the right questions upfront to reveal whether a manufacturing partner has demonstrated capability backed by a verifiable track record — not just sales promises.
1. Single-site vs. multi-site manufacturing — how to verify it’s truly single-site, and why multi-site introduces dual validation, inter-site logistics, and months of added complexity
2.Quantify tech transfer success — the performance metrics that predict outcomes, pilot run requirements, and why undocumented process knowledge causes 50% of transfers to fail
3. Regulatory excellence vs. basic compliance — how to distinguish FDA expertise from minimum cGMP, including what to look for in Form 483 history, warning letters, and inspection timelines
4. High-potency manufacturing capabilities — the specialised containment suites, HVAC systems, and trained personnel most CDMOs cannot provide or retrofit
5. Technical capabilities beyond basic GMP — modified-release formulations, Wurster coating, in-house analytical method development, and ICH stability testing
6. Utilisation rates & scale-up capability — why CDMOs above 85–90% utilisation cannot support growth without 12–18 months of capital investment and lead time
7. Geographic risk assessment — how 25% API tariffs, the Biosecure Act, and geopolitical risk are fundamentally changing the offshore vs. domestic manufacturing cost calculation
8. Digital systems & data integrity — electronic batch records, 21 CFR Part 11 compliance, ALCOA+ audit trails, and the gaps that trigger FDA warning letters
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