How To Choose The Right CDMO

By Amalia Soenens & Lindsey Wolf

Selecting a contract development and manufacturing organization (CDMO) is a critical decision that influences a therapeutic program's regulatory and clinical trajectory. Unlike traditional biologics, advanced therapies involve living cells and biology-dependent vectors that react dynamically to processing conditions. Small deviations can severely impact product safety, quality, and potency.

Regulatory data highlights the stakes: nearly three-quarters of recent FDA Complete Response Letters involved manufacturing or quality issues, and resolving these inquiries takes an average of eight months. Consequently, evaluating a CDMO requires looking beyond standard facility capabilities and capacity. True alignment involves assessing an organization’s deep scientific expertise, translational experience, and process development philosophy. Engaging a highly collaborative partner early ensures a robust chemistry, manufacturing, and controls (CMC) strategy, protecting the program from costly clinical holds and regulatory delays.

Review the complete evaluation framework to establish a manufacturing foundation built for long-term clinical and regulatory success.