Beyond GMP: Selecting and Managing CDMOs for Biological Products

Articulate why regulatory compliance is an entry criterion, not a differentiator, and identify the three failure modes that standard audits consistently miss for biological products.

GMP compliance is the starting point for any CDMO shortlist. Yet for many biotech and biopharma companies, it remains the primary lens through which manufacturing partners are evaluated. This forum challenges that assumption and offers a more rigorous, experience-driven approach to CDMO selection and management.

The first presentation explores how structured project management thinking directly shapes the quality of CDMO relationships. From scoping and risk mapping to milestone ownership and performance accountability, it reveals what sponsors can do differently at every stage of the engagement to avoid costly misalignments that derail programmes.

The second presentation makes the case that biological products carry inherent risks that standard compliance audits are simply not designed to surface. Technology mismatches, operational fragility, and failures in partnership culture have led to the closure of programmes operating in fully GMP-certified facilities. Attendees will leave with a practical, multi-dimensional scoring framework for evaluating CDMOs across the dimensions that actually predict success.

Together, these sessions offer a candid, expert-led perspective on what it takes to select well, manage effectively, and build CDMO partnerships that hold up under pressure.