Choosing The Right CDMO For Controlled Substance Development And Manufacturing: A Guide To Evaluating Technical Expertise, Compliance, And Security

Controlled substance programs carry requirements that conventional small molecule manufacturing does not: government licensing, a closed and fully documented chain of custody, country-specific import and export permits, and inspection readiness. Yet compliance alone does not carry a difficult molecule through scale-up. Written by Tobias Haag (Process Development), Matthias Pabst (Production), and Anna Stamm (Quality Assurance), this white paper sets out the factors sponsors should weigh when selecting a CDMO partner, from security systems and audit history to impurity control and solid-state challenges. It also describes how one Swiss site approaches custody, analytics, and batch flexibility from clinical to commercial scale, and closes with questions for your own selection process.

Explore the evaluation framework to sharpen how you assess potential partners.