What’s Inside
Five Parts, in the Order an Evaluation Actually Runs
Choosing a CDMO is one of the most consequential decisions a program leader makes, and one of the
hardest to evaluate from a capability deck. The right partner accelerates your timeline and
strengthens your regulatory position. The wrong one often isn’t apparent until a GMP run goes
sideways or an FDA question takes eight months to resolve. This guide is the framework we use to
tell the difference.
Part One
The Advanced Therapy Manufacturing Landscape
Understanding the environment your program operates in, before you choose a partner — and what the FDA data tells us about CMC risk.
Part Two
Modality Expertise and Development Integration
Why direct experience with your biology matters more than any capability list, and what integrated teams across PD, analytics, and GMP look like.
Part Three
Process Philosophy, Materials Strategy, and Facility Readiness
Defining CPPs early, qualifying materials in development rather than at transfer, and what facility infrastructure really tells you.
Part Four
Partnership Model and the Questions That Reveal the Most
What a high-quality CDMO partnership looks like day to day, and how to tell whether a CDMO is the right fit before you sign anything.
Part Five
From Evaluation to Decision
The scorecard, a sequencing model for the evaluation itself, and the decision pitfalls worth avoiding.
Reference
Frequently Asked Questions
The questions program leaders bring to us most often, grouped as a standalone reference at the back of the guide.
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